AUGUST 2010

AUGUST 2010

WEEK ENDING AUGUST 28

PRODUCT LORAZEPAM Injection, USP 2 mg/mL. 10 - 1mL vials, Rx only, For IM or IV use, NDC 0409-6778-02. CODE Lot Number: 88643EV01
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen, Chesterbrook, PA,
Manufacturer: Hospira Inc., Lake Forest, IL. .
REASON Temperature Deviation; product had not been stored according to manufacturer's labeled temperature requirements prior to distribution.
VOLUME OF PRODUCT IN COMMERCE 163 units
DISTRIBUTION FL

PRODUCT Kit for the Preparation of Technetium Tc99m Pentetate Injection (DTPA), 10 mL vial, a) 5 vial kits (NDC 45567-0010-1), b) 30 vial kits (NDC 45567-0010-2), Rx only.
CODE Lot #s: 2414, Exp. Sept 30, 2010; 2416 Exp. June 30, 2011
RECALLING FIRM/MANUFACTURER
Pharmalucence, Inc., Bedford, MA,
REASON Product Lacks Stability: Technetium Tc99m Pentetate Injection does not maintain 90% Radiochemical Purity (RCP) for up to six hours after reconstitution with up to 160 mCi of Technetium Tc99m.
VOLUME OF PRODUCT IN COMMERCE
15,595 vials
DISTRIBUTION
Nationwide, Costa Rica, Bermuda, Israel, Republic of Panama

PRODUCT ALTACE (ramipril) capsules, 2.5 mg, 100-count bottle, Rx only; NDC 61570-111-01. CODE Lot Number 57425, Exp 10/12
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals Inc., Bristol, TN,
REASON Subpotent (Single Ingredient Drug): This product is being recalled because stability samples found that it was subpotent at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE
16,382 bottles
DISTRIBUTION
Nationwide

PRODUCT
1) Triple Antibiotic (Polymyxin B Sulfates, Bacitracin Zinc, Neomycin, Pramoxine HCl) Ointment, Maximum Strength, Net Wt 0.5 oz. (14 gm), OTC, 1), NDC 11917-0823-34, UPC 3 11917 09750 3; 2) UPC 0 84579 10078 1.

2) Triple Antibiotic (Polymyxin B Sulfates, Bacitracin Zinc, Neomycin, Pramoxine HCl) Ointment, Maximum Strength, Net 1 oz. (28 gm), OTC, NDC 11917-0823-56, UPC 3 11917 09749 7.
CODE
1) Lot Number: L909067, Exp: 09/11; L909055, Exp: 09/11;
2) Lot Number: L909066, Exp: 09/11
RECALLING FIRM/MANUFACTURER
Actavis Mid Atlantic LLC, Lincolnton, NC,
REASON Degradation failure: 6 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
165,600 tubes
DISTRIBUTION
Nationwide

PRODUCT Cephalexin for Oral Suspension, USP, 125 mg/5 mL, 100 mL bottle, Rx only, NDC 0093-4175-73.
CODE Lot # 30301221A, Exp 3/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: TEVA Pharmaceuticals USA, Inc., Fairfield, NJ.
REASON
Subpotent (single ingredient) Drug: The product was found to be subpotent at the 12 month stability time point.
VOLUME OF PRODUCT IN COMMERCE
12,776 bottles
DISTRIBUTION
Nationwide

PRODUCT Hylenex recombinant (Hyaluronidase Human) Injection, 150 USP units/mL, Single Dose Vial, Rx Only, 1) NDC 60977-319-03, 2) NDC 60977-319-99.
CODE
Lot Numbers: 909775, Exp: 08/2010; 909777, Exp: 08/2010; 909779, Exp: 08/2010; 911728, Exp: 04/2011; 912462, Exp: 07/2011; 912916, Exp: 08/2011
RECALLING FIRM/MANUFACTURER
Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN,
REASON Presence of Foreign Substance: The affected lots were found to contain small, flake-like glass particles.
VOLUME OF PRODUCT IN COMMERCE
34,032 vials
DISTRIBUTION
Nationwide

PRODUCT
1) Children's ZYRTEC (Cetirizine HCl) Oral Solution, 5 mg, 4 OZ Bottle, Dye-Free Su gar-Free, Grape Syrup, OTC, UPC Code 3 0045-0209-047.

2) Children's TYLENOL (Acetaminophen) Oral Suspension, 160 mg, 4 oz Bottle, Dye-Free, Cherry Flavor, OTC, UPC Code 3 0045-0166-043.

3) Children's TYLENOL (Acetaminophen) Oral Suspension, 160 mg, 4 oz Bottle, Dye-Free, Grape SPLASH Flavor, OTC, UPC Code 3-0045-0296-047.

4) Children's TYLENOL Plus COLD & STUFFY NOSE (Acetaminophen and Phenylephrine HCl), Oral Suspension, 160 mg and 2.5 mg, 4 oz Bottle, Dye-Free, Grape Flavor, OTC, Code 3 0045-0253-040.

5) Children's TYLENOL Plus Multi-Symptom COLD (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, 4 oz Bottle, Dye-Free, Cherry Flavor, OTC, UPC Code 3 0045-0255-044.

6) Children's TYLENOL Plus FLU (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz Bottle, Bubble Gum Flavor, OTC, UPC Code 3 0045-0386-052.

7) Children's TYLENOL Plus COLD (Acetaminophen, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz Bottle, Grape Flavor, OTC, UPC Code 3 0045-0387-059.

8) Children's TYLENOL Plus COLD & ALLERGY(Acetaminophen, Diphenhydramine HCl, and Phenylephrine HCl), Oral Suspension, 160 mg, 12.5 mg, and 2.5 mg, Oral Suspension, 4 oz Bottle, Bubble GUM Flavor, OTC, UPC Code 3 0045-0390-059.

9) Children's TYLENOL Plus Multi-Symptom COLD (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), Oral Suspension, 160 mg, 5 mg, 2.5 mg, and 1 mg, Oral Suspension, 4 oz, Grape Flavor, OTC, UPC Code 3 0045-.
CODE
1) Lot numbers: ASM308, ASM388, and ASM433;

2) Lot numbers: ALM336, ALM404, AMM312, ASM317, ASM328, and ASM396;

3) Lot numbers: ALM302, ALM351, ALM411, ALM412, AMM346, ASM315, ASM316, and ASM329;

4) Lot number: ALM409;

5) Lot numbers: ALM353, AMM309, AMM344, and ASM392;

6) Lot numbers: AJM405, AJM417, ALM306, ALM315, ALM339, ALM340, AMM313, AMM347, APM401, APM402, and APM403;

7) Lot numbers: ALM335, ASM369, and ASM395;

8) Lot number: AHM453;

9) Lot numbers: ALM303, ALM304, ALM305, ALM354, ALM356, ALM410, ALM419, ALM420, APM406, APM407, ASM307, and ASM340
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA,
REASON Defective Container: some products have thin walled bottles defect.
VOLUME OF PRODUCT IN COMMERCE
4,591,584 bottles
DISTRIBUTION
Nationwide

PRODUCT Prilosec Omeprazole Delayed Release Capsules, USP 20mg, 100UD NDC #68084-128-01, Dose NDC #68084-128-11. CODE
Lot #, 083321, Exp. Date, 06/2010; Lot #, 083150, Exp. Date, 12/2010; Lot #, 083150A, Exp. Date, 01/2011; Lot # 083132, Exp. Date, 06/2010; Lot # 093318, Exp. Date 02/2011; Lot # 092327, Exp. Date 01/2011; Lot # 091476, Exp. Date 11/2010; & Lot # 090656, Exp. Date 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH,
Manufacturer: Apotex Inc., Toronto Ontario, Canada.
REASON GMP Deviations (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
52,791 units/100/20 mg capsules
DISTRIBUTION
Nationwide

PRODUCT
1) PEPCID Complete (Famotidine, Calcium Carbonate, Magnesium Hydroxide) Tablet, 10 mg, 800 mg, 165 mg; 50 Tropical Fruit flavor Chewable Tablets, Bottle, OTC; NDC 16837-246-50.

2) PEPCID AC (Famotidine) Tablets, 10 mg, 90 Count Bottle, OTC, NDC 16837-872-90. CODE
1) Lot Number: BEF062, Exp: May 2013;
2) Lot Number: BFF010, Exp: November 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Merck, Ft Washington, PA,
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR.
REASON Defective Container: small number of bottles have been punctured at the bottom edge during the packaging process.
VOLUME OF PRODUCT IN COMMERCE
Pepcid Complete 15,264 bottles; Pepcid AC 360 bottles
DISTRIBUTION
Nationwide

Natural Wellness, Inc. Issues a Recall of Masxtreme Capsules, Marketed as a Dietary Supplement

Natural Wellness is recalling MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis has determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil. Tadalafil is an FDA-Approved drug used to treat erectile dysfunction (ED), making the MasXtreme an unapproved new drug.

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc.

Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441.

Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm.

WEEK ENDING AUGUST 21

PRODUCT Sandimmune CycloSporine Capsules USP 100mg capsules.
CODE
Lot No: 092326, Exp. Date 03/2011 & Lot No: 094101, Exp. Date, 04/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH,
Manufacturer: Apotex Corp., Weston, FL..
REASON
The Apotex Recall was conducted due to a potential GMP violations.
VOLUME OF PRODUCT IN COMMERCE
2080 units/100/100 mg capsules
DISTRIBUTION
Nationwide

PRODUCT Adagen (pegademase bovine) injection, 250 units per mL, Sterile for intramuscular injection only, four 1.5 mL single-dose vials, Rx Only; NDC 57665-001-01.
CODE Lot # 9150
RECALLING FIRM/MANUFACTURER
Sigma-tau Pharmasource, Inc., Indianapolis, IN
REASON
Impurities/Degradation products found during routine stability testing. The impurity level was 2.1%, which is above the specification level of 2%.
VOLUME OF PRODUCT IN COMMERCE
282 4-vial packs
DISTRIBUTION
TN, France, Australia

PRODUCT Losartan Potassium and Hydrochorothiazide tablets, 100mg/12.5 mg, Rx only 90 tablets, NDC 0781-5817-92.
CODE
Lot Number: Z1809, Exp. Date: 01-2013; Lot Number: Z1895, Exp. Date: 02-2013 and Lot Number: E004934, Exp. Date: 02-2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck and Co., Inc., Wilson, NC, .
Manufacturer: Merck Sharp & Dohme Ltd., Cramlington North D, UK.
REASON Labeling error: The front portion of the bottle label correctly states the product strength as "100mg/12.5mg", while the text on the back portion of the bottle label incorrectly states "Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide."
VOLUME OF PRODUCT IN COMMERCE
16,690 unit packages
DISTRIBUTION CO

PRODUCT Acetaminophen Tablets, Acetaminophen 325 mg., 100 tablet bottles, OTC, sold under the following brand names: Good Neighbor Pharmacy Pain Relief, NDC 24385-403-78; Care One Pain Relief Care One, NDC 41520-403-78; H.E.B. Pain Relief, NDC 37808-403-78; HyVee Pain Relief, NDC 42507-403-78; Leader Pain Reliever, NDC 37205-031-78; CVS Pain Relief, NDC 59779-403-78; Sunmark Pain reliever, NDC 49348-009-10; Hannaford Pain Reliever, NDC 41268-403-78; Equaline pain relief, NDC 41163-403-78; TopCare Pain Relief, NDC 36800-0403-78; Goodsense Pain Relief, NDC 0113-0403-78.
CODE
Units: 0BE2230, 0CE1359, 0CE1623, 0CE2533, 0DE1161, 0DE1610 and 0EE1594
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI,
REASON The liver warning section of the product label warns that severe liver damage may occur if an adult takes more than 8 tablets in 24 hours. The warning should state that liver damage may occur if an adult takes more than 12 tablets in 24 hours.
VOLUME OF PRODUCT IN COMMERCE
60,594 bottles
DISTRIBUTION
Nationwide

PRODUCT Loratadine Oral Solution, 5 mg per 5 mL, Antihistamine, Fruit Flavored Syrup, 120 mL (4 Fl oz) Bottle, OTC, NDC 54838-538-40.
CODE
Control Numbers (Batches): 5890A, Exp. 02/12; 5891A, Exp. 02/12; 5892A, Exp. 02/12; 5893A, Exp. 02/12; 5894A, Exp. 02/12; 5895A, Exp. 02/12; 5896A, Exp. 02/12; 5897A, Exp. 02/12; 5898A, Exp. 02/12; 5899A, Exp. 02/12
RECALLING FIRM/MANUFACTURER
Silarx Pharmaceuticals, Inc., Spring Valley, NY,
REASON
Presence of Particulate Matter: The manufacturer received one complaint of minute particulate in Loratadine Oral Solution, Control # 5890. The firm has decided to recall a total of ten lots as a precaution.
VOLUME OF PRODUCT IN COMMERCE
81,746 Bottles were shipped (24 were damaged/destroyed resulting in a total of 81,722 bottles)
DISTRIBUTION
Nationwide

PRODUCT MiraLAX (Polyethylene Glycol 3350) Powder for Solution, Laxative, 17g/dose, 30 ONCE-DAILY DOSES, Net Wt 17.9 oz (510g), OTC; NDC 11523-7234-4. Product is packaged in a "Wave" bottle presentation as single, twin packs and bonus pack. 1) Single Pack: Item # 80628 and 80770; Item UPC 0-41100-82071-6 and 0-41100-80770-0; Case: UPC 000-41100-80628-4 and 100-41100-80770-7. 2) Twin Pack: Item # 80650; Item UPC 000-41100-80650-5; Case UPC 100-411000-80650-2. 3) Bonus Pack: Item # 80770, Item UPC: 0-41100-80770-0; Case: UPC 100-41100-80770-7. The Bonus Pack has a separate tertiary lot number which appears on the bottom of the unit that is different from the recalled lot number. The recalled lot number is not visible due to the tertiary packaging configuration of the Bonus Pack. 4) Canada Distribution Label: RestoraLAX. Product is packaged in a "Wave" bottle presentation as single pack, UPC 0-56219-82330-5. CODE
Lot Number: E-MLX-42, E-MLX-43, E-MLX-44, E-MLX-45, E-MLX-46, E-MLX-51, E-MLX-59, E-MLX-60, E-MLX-61, E-MLX-65, E-MLX-78, E-MLX-79, E-MLX-80, E-MLX-81, E-MLX-82, E-MLX-83, E-MLX-84, E-MLX-86, E-MLX-97, E-MLX-98, E-MLX-99, E-MLX-113, E-MLX-114, E-MLX-115, E-MLX-116, F-MLX-2, F-MLX-3, F-MLX-19, F-MLX-20, F-MLX-21, F-MLX-22, F-MLX-24, F-MLX-31, F-MLX-32, F-MLX-54. Tertiary Lot Number on Bonus Pack: 000936NM, 001036NM, 001136NM, 001536NM, 001636NM, 002836NM, 002936NM, 003036NM, 003136NM, 003236NM, 017532NM, 923836NM, 923936NM, 924036NM, 924136NM, 924236NM, 930036ANM, 930036NM, 931336ANM, 931336NM, 933631ANM, 933631BNM, 933631NM, 933836ANM, 933836CNM, 933836NM, 935536NM, 936236NM. E-MLX-64 (Canada distribution only)
RECALLING FIRM/MANUFACTURER
Schering Corp., Miami Lakes, FL,
REASON Defective Container: products may contain defective (burnt) cap liners and the product may have an off odor and off taste.
VOLUME OF PRODUCT IN COMMERCE
4,698,069 bottles US/ 113,340 bottles Canada
DISTRIBUTION
Nationwide, Canada

PRODUCT
1) Cleocin Phosphate IV (clindamycin) injection, 300 mg/50 mL in 5% Dextrose, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3414, Rx only, a) NDC 0009-3381-01, (IV Bag), b) NDC 0009-3381-02 (Unit of Sale).

2) Cleocin Phosphate IV (clindamycin) injection, 600 mg/50 mL in 5% DEXTROSE, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3415, Rx only, a) NDC 009-3375-01 (IV Bag), b) NDC 0009-3375-02 (Unit of Sale).

3) Cleocin Phosphate IV (clindamycin) injection, 900 mg/50 mL in 5% Dextrose, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3416, Rx only, a) NDC 009-3382-01 (IV Bag), b) NDC 0009-3382-02 (Unit of Sale).
CODE
1) Lot Numbers: NC049676, Exp. 08/10; NC050773, Exp. 10/10; NC052100, Exp. 12/10; NC052118, Exp. 12/10; NC052241, Exp. 01/11; NC052415, Exp. 01/11; NC052431, Exp. 01/11; NC052704, Exp. 02/11; NC053108, Exp. 03/11; NC054429, Exp. 05/11; NC056283, Exp. 09/11; NC056648, Exp. 10/11; NC057430, Exp. 11/11; NC058545, Exp. 01/12;

2) Lot Numbers: NC049825, Exp. 08/10; NC050591, Exp. 09/10; NC050674, Exp. 10/10; NC050823, Exp. 10/10; NC051029, Exp. 10/10; NC051425, Exp. 11/10; NC051458, Exp. 11/10; NC051524, Exp. 11/10; NC051599, Exp. 11/10; NC052134, Exp. 12/10; NC052159, Exp. 12/10; NC052175, Exp. 12/10; NC052217, Exp. 01/11; NC052274, Exp. 01/11; NC052308, Exp. 01/11; NC052324, Exp. 01/11; NC052365, Exp. 01/11; NC052373, Exp. 01/11; NC052407, Exp. 01/11; NC052548, Exp. 01/11; NC052589, Exp. 01/11; NC052605, Exp. 01/11; NC052621, Exp. 01/11; NC052662, Exp. 02/11; NC052688, Exp. 02/11; NC052720, Exp. 02/11; NC052761, Exp. 02/11; NC052787, Exp. 02/11; NC052902, Exp. 02/11; NC053009, Exp. 02/11; NC053025, Exp. 02/11; NC053041, Exp. 02/11; NC053181, Exp. 03/11; NC053207, Exp. 03/11; NC053223, Exp. 03/11; NC053249, Exp. 03/11; NC053470, Exp. 03/11; NC053496, Exp. 03/11; NC053512, Exp. 03/11; NC053538, Exp. 04/11; NC053553, Exp. 04/11; NC053835, Exp. 04/11; NC053934, Exp. 04/11; NC053959, Exp. 04/11; NC053975, Exp. 04/11; NC053991, Exp. 04/11; NC054015, Exp. 05/11; NC054064, Exp. 05/11; NC054072, Exp. 05/11; NC054205, Exp. 05/11; NC054221, Exp. 05/11; NC054445, Exp. 06/11; NC054460, Exp. 06/11; NC054692, Exp. 06/11; NC054718, Exp. 06/11; NC054734, Exp. 06/11; NC054874, Exp. 07/11; NC054908, Exp. 07/11; NC054916, Exp. 07/11; NC054957, Exp. 07/11; NC054973, Exp. 07/11; NC055020, Exp. 07/11; NC055046, Exp. 07/11; NC055087, Exp. 07/11; NC055111, Exp. 07/11; NC055160, Exp. 07/11; NC055277, Exp. 07/11; NC055509, Exp. 08/11; NC055582, Exp. 08/11; NC055616, Exp. 08/11; NC055632, Exp. 08/11; NC055657, Exp. 08/11; NC055905, Exp. 09/11; NC056069, Exp. 09/11; NC056085, Exp. 09/11; NC056135, Exp. 09/11; NC056200, Exp. 09/11; NC056234, Exp. 09/11; NC056317, Exp. 09/11; NC056440, Exp. 10/11; NC056499, Exp. 10/11; NC056523, Exp. 10/11; NC056598, Exp. 10/11; NC056721, Exp. 10/11; NC056861, Exp. 10/11; NC056986, Exp. 11/11; NC057133, Exp. 11/11; NC057182, Exp. 11/11; NC057273, Exp. 11/11; NC057315, Exp. 11/11; NC057406, Exp. 11/11; NC057414, Exp. 11/11; NC057604, Exp. 12/11; NC057653, Exp. 12/11; NC057661, Exp. 12/11; NC059410, Exp. 03/12;

3) Lot Numbers: NC049759, Exp. 08/10; NC050625, Exp. 09/10; NC050799, Exp. 10/10; NC050948, Exp. 10/10; NC050997, Exp. 10/10; NC051326, Exp. 11/10; NC051375, Exp. 11/10; NC051631, Exp. 11/10; NC051961, Exp. 12/10; NC051987, Exp. 12/10; NC052001, Exp. 12/10; NC052027, Exp. 12/10; NC052043, Exp. 12/10; NC052068, Exp. 12/10; NC052191, Exp. 12/10; NC052340, Exp. 01/11; NC052456, Exp. 01/11; NC052530, Exp. 01/11; NC052563, Exp. 01/11; NC052647, Exp. 01/11; NC052746, Exp. 02/11; NC053298, Exp. 03/11; NC053314, Exp. 03/11; NC053330, Exp. 03/11; NC053355, Exp. 03/11; NC053371, Exp. 03/11; NC053454, Exp. 03/11; NC053587, Exp. 04/11; NC053694, Exp. 04/11; NC053728, Exp. 04/11; NC053751, Exp. 04/11; NC053785, Exp. 04/11; NC053819, Exp. 04/11; NC054247, Exp. 05/11; NC054262, Exp. 05/11; NC054395, Exp. 05/11; NC054403, Exp. 05/11; NC054635, Exp. 06/11; NC054650, Exp. 06/11; NC054668, Exp. 06/11; NC054767, Exp. 06/11; NC055061, Exp. 07/11; NC055178, Exp. 07/11; NC055202, Exp. 07/11; NC055210, Exp. 07/11; NC055491, Exp. 08/11, NC055517, Exp. 08/11; NC055558, Exp. 08/11; NC055574, Exp. 08/11; NC055673, Exp. 08/11; NC055699, Exp. 08/11; NC055723, Exp. 08/11; NC056119, Exp. 09/11; NC056184, Exp. 09/11; NC056366, Exp. 09/11; NC056416, Exp. 10/11; NC056671, Exp. 10/11; NC056747, Exp. 10/11; NC056895, Exp. 10/11; NC056911, Exp. 10/11; NC056945, Exp. 10/11; NC057034, Exp. 11/11; NC057364, Exp. 11/11; NC057372, Exp. 11/11; NC057448, Exp. 11/11; NC057570, Exp. 12/11; NC057703, Exp. 12/11; NC057737, Exp. 12/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY,
Manufacturer: Baxter Healthcare Corp., Round Lake, IL.
REASON
Presence of Foreign Substance(s): the active pharmaceutical ingredient (API) used in the affected lots may have been contaminated with paraffin wax.
VOLUME OF PRODUCT IN COMMERCE
6,141,216 bags
DISTRIBUTION
Nationwide, Puerto Rico, Aruba and Costa Rica

J & H Besta Recalls Slim- 30 Herb Supplement to Include Lot 6032101

J & H Besta Corp. of Hicksville, NY, is recalling Slim-30 Herb Supplement Lot 6032101 because it was found to contain undeclared Desmethyl Sibutramine, similar in structure to Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.

Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2.

The product was sold to distributors and retail stores nationwide and via internet sales.

Consumers should not consume Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund.

Consumers with questions should contact Jason Wang at 516-735-1436, Monday - Friday, 10:00 am - 5:30 pm, EDT.

Glow Industries, Inc. Issues Recall of Mr. Magic Male Enhancer from Don Wands Amended

Glow Industries, Inc., Perrysburg, OH, is recalling the company's product sold under the name of Mr. Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this recall after lab analysis has found the Mr. Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr. Magic Male Enhancer an unapproved new drug. These active ingredients are not listed on the product label. Product manufactured containing lot numbers 9041401, 251209 and 8121904 are included in this recall.

The Mr. Magic Male Enhancer recall includes:

Product Name	Lot Code	UPC Code
Mr. Magic 1 ct. Capsule Card	9041401 and 251209	648658123001
Mr. Magic 3 ct. Capsule Bottle	9041401 and 8121904	648658123018
Mr. Magic 6 ct. Capsule Bottle	9041401 and 8121904	648658123025
Mr. Magic 12 ct. Capsule Bottle	9041401 and 8121904	648658123032
Mr. Magic Display of 24; 1 ct. Capsule Cards	9041401 and 251209	648658123043
Mr. Magic 20 ct. Capsule Bottle	9041401 and 8121904	648658123056

Glow Industries, Inc. advises any customer in possession of Mr. Magic Male Enhancer from Don Wands capsules to call (419) 350-2726, between the hours of 8 a.m and 5 p.m, Monday through Friday, Eastern Standard Time for instructions on the product return and credit process. Glow Industries, Inc. is notifying its distributors and retailers by a recall letter and phone calls to arrange for return of recalled product in their possession.

NBTY Acquisition LLC Dba Leiner Health Products Issues Recall on Undeclared Soy in Air Shield Effervescent Tablets, Air Protector Effervescent Tablets, Immune System Support Effervescent, and Airhealth Effervescent Tablets And Stick Packs

NBTY Acquisition LLC, dba Leiner Health Products of Ronkonkoma, New York is recalling Air Shield, Air Protector, Immune System Support, and AirHealth Effervescent 10 Tablet containers and Stick Packs, 8 stick containers, because they may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume these products.

The Effervescent Tablet product was sold under the names Air Shield, Air Protector, Immune System Support, and AirHealth, under various brands shown in the table below. The Stick Packs were sold only under Wal-born and Safeway brands.

The products listed below were distributed throughout the United States via retail stores.

Product No.	Description	UPC Codes	Label	Expiration Dates	Lot Numbers
53220	AirHealth Lemon-Lime, 10 Tablets per Box	6 05388 66178 4 7 19283 59047 3	Equate (Walmart) Meijer	1/31/12 and earlier	All
53220	Air Protector Lemon-Lime, 10 Tablets per Box	0 41163 44076 0	Equaline (SuperValue and Albertson's)	1/31/12 and earlier	All
53220	Air Shield Lemon-Lime 10 Tablets per Box	0 36800 14551 1 0 74970 53220 5 0 50428 07878 5 3 12333 93141 9 0 00000 88266 8	Top Care Your Life CVS Longs Wellness Trader Darwin's (Trader Joe's)	1/31/12 and earlier	All
53220	Immune System Support Lemon-Lime, 10 Tablets per Box	0 74990 73220 3	Target	1/31/12 and earlier	All
53140	AirHealth Orange, 10 Tablets per Box	6 05388 66146 3 3 21130 78726 6 3 21130 78726 6 8 40986 01982 1 0 74970 53140 6 0 10939 06044 0	Equate Safeway Safeway Select Premier Value Your Life Sunmark	1/31/12 and earlier	All
53140	Air Protector Orange, 10 Tablets per Box	0 41163 43021 1	Equaline (SuperValue and Albertson's)	1/31/12 and earlier	All
53140	Air Shield Orange 10 Tablets per Box	0 74970 53140 6 0 50428 07877 8 3 12333 93131 0 0 00000 88267 5	Your Life CVS Longs Wellness Trader Darwin's (Trader Joes)	1/31/12 and earlier	All
53140	Immune System Support Orange, 10 Tablets per Box	0 74990 73140 4	Target	1/31/12 and earlier	All
53142	Air Shield Orange, 20 Tablets per Box (2 pack)	0 50428 09706 9	CVS	1/31/12 and earlier	All
54320	Air Shield Pink Grapefruit, 10 Tablets per Box	0 50428 11516 9	CVS	1/31/12 and earlier	All
83140	Immune System Support Orange Tablets, 10 Tablets per Box	0 74990 73140 4	Target Up & Up	1/31/12 and earlier	All
85322	Immune System Support Lemon Lime Tablets, 10 Tablets per Box	0 74990 73220 3	Target Up & Up	1/31/12 and earlier	All
53710	Walborn Lemon Lime Stick Pack (powder) 8 Stick Count per Box 3.8g per Stick	3 11917 08770 2	Walborn (Walgreen's)	1/31/12 and earlier	All
53710	AirHealth Lemon Lime Stick Pack (powder) 8 Stick Count per Box 3.8g per Stick	3 21130 78733 4	Safeway	1/31/12 and earlier	All

Consumers who have any of these products in their possession should call 1-888-534-6370, Monday – Friday 9 am – 7 pm EDT for further instructions.

WEEK ENDING AUGUST 14

PRODUCT

1) 72 HOURS [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 1-count pouch and 10-count bottles, OTC.

2) 72 HOURS [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 481.71 mg, 1-count pouch and 10-count bottle, OTC, UPC 8 55892 00326 0 and 8 51780 002018.

3) AMOUR AGAIN [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 2-count pouch and 10-count bottle.

4) AROUSIN [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 3-count pouch and 15-count bottle, OTC.

5) Clyamax [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 4-count pouch and 16-count bottle, OTC.

6) DEPTH CHARGE [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext., Eurycoma Longifolia Extract, Tribulus Terrestris Extract, L-Arginine] capsules, 380 mg, 2-count bottle, 8-count bottle, and 20-count bottle, OTC.

7) Enhancement [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 16-count bottle, 32-count bottle, and 64-count bottle, OTC.

8) ERECTZIA [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 2-count bottle, 4-count bottle, and 15-count bottle, OTC.

9) EREXA [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 2-count pouch, 4-count pouch, and 16-count bottle, OTC.

10) ERE-XXX ELITE BODY [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 375 mg, 2-count pouch and 16-count bottle, OTC.

11) ERE-XXX Maxi Elite [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed, Cordyceps Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 16-count bottle, OTC.

12) EROUSA [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 489 mg, 1-count pouch and 12-count bottle, OTC.

13) EZEREX [Proprietary Blend of White Willow Bark, Bombyx Mori ext., Cordyceps ext. 7%, Horny Goat Weed (Epimedium 10%), Ginger Root, Oyster ext., Charcoal, Green Coffee Bean ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Korean Ginseng, Wolfberry Ext.] 425mg; Vitamin B3 (Niacin) 0.02 mcg; capsules, 4-count bottle and 20-count bottle, OTC.

14) Finally On DEMAND [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 8-count bottle, OTC, Item# FIN0D01A.

15) LIBIPLUS [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425mg, 1-count blister, OTC, UPC 8 04879 13018 5.

16) LOVE FUEL [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Horny Goat Weed, Oyster Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 4-count pouch (UPC 0 05643 89017 9) and 16-count bottle (UPC 0 00052 49739 1), OTC.

17) RAINBOW ROCKET [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Horny Goat Weed, Oyster Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425mg, 4-count pouch (UPC 0 07642 17893 7) and 16-count bottle (UPC 0 01457 69031 8), OTC.

18) RED HOT SEX [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Ginger powder 5%, Wolfberry Ext.] capsules, 425mg, 1-count pouch and 10-count bottle, OTC.

19) SEXUAL SURGE [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Pwdr., Rehmannia Root Pwdr, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425mg, 16-count bottle, OTC, Barcode 2570001.

20) STAMIN IT [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordycepts Ext. 7%, Oyster Ext., Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Yohimbe 10%, Wolfberry Ext.] capsules, 375 mg, 2-count pouch, OTC.

21) STAMINIL [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Yohimbe 10%, Wolfberry Ext.] capsules, 375 mg, 2-count pouch, 20-count pouch, and 20-count bottle, OTC. Proudly made in the U.S.A.

22) TACKTOL [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed, Cordyceps Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext., Tongkat Ali, Tribulus Terrestris, 20-Beta-Hydroxyecdysterone] capsules, 426 mg, 2-count pouch (barcode 7350034170150) and 16-count bottle (barcode 7350034170143), OTC.

23) TopViril [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Pwdr., Rehmannia Root Pwdr, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 20-count bottle, OTC, N*3734320.

24) Vaxitrol [Proprietary Blend of Niacin, Horny Goat Weed (Epimedium extract 10%), Cordyceps extract 40%, Yohimbe 8%, Schizandra berry, Rehmannia Root, Korean Ginseng, Bombyx mori extract, Oyster extract and Ginger Root extract 5%)] capsules, 336.8 mg, 16-count bottle, OTC, UPC 7 2689091118 8.

25) VIERECT [Proprietary Blend of White Willow Bark, Bombyx Mori Ext., Ginger Root, Horny Goat Weed (Epimedium 10%), Cordyceps Ext. 7%, Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry, Rehmannia Root, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, OTC, 4-count bottle and 16-count bottle.

26) VIGOR 100 [Proprietary Blend of White Willow Bark 25%, Bombyx Mori Ext., Ginger Root Powder, Horny Goat Weed (Epimedium 10%), Cordyceps 7% Ext., Oyster Ext., Charcoal, Green Coffee Bean Ext., Vinpocentine, Schizandra Berry Powder, Rehmannia Root Powder, Vitamin B3 (Niacin), Korean Ginseng, Wolfberry Ext.] capsules, 425 mg, 1-count pouch, 2-count pouch, 3-count pouch, 10-count pouch, and 16-count bottle, OTC.

27) WHATZ UP RX [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Charcoal, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 425 mg, 8-count bottle, OTC.

28) XTREAMEXCITE [Proprietary Blend of White Willow Bark, Bombyx Mori L, Ginger Root, Cordyceps Extract, Epimedium Extract, Oyster, Green Coffee Bean Extract, Vinpocentine, 2DG, Saffron Crocus, Wolfberry] capsules, 375 mg, 8-count bottle, OTC.

29) ZEN ERECT [Proprietary Blend of White Willow Bark, Bombyx Mori Extract, Cordyceps 7% Extract, Epimedium 10% Extract, Ginger Root Extract, Charcoal, Green Coffee Bean Extract, Vinpocentine, Cridium Monnier, L-Arginine Base, Tribulus Terrestris Extract, Schizandra Berry Powder, Rehmannia Root Powder, Niacin, Korean Ginseng] capsules, 425 mg, 16-count bottle, OTC.

CODE

1) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;

2) All lots that contain XXX-705-XX, where X is any number;

3) All lots that contain XXX-705-XX, where X is any number;

4) All lots that contain XXX-705-XX, where X is any number;

5) All lots that contain XXX-705-XX, where X is any number;

6) All lots that contain XXX-807-XX or XX-807-XX, where X is any number;

7) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;

8) All lots that contain XXX-705-XX or XX-705-XX, where X is any number;

9) All lots that contain XXX-705-XX, where X is any number;

10) All lots that contain XXX-705-XX or XX-705-XX, where X is any number;

11) All lots that contain XXX-705-XX, where X is any number;

12) All lots that contain XXX-705-XX, where X is any number;

13) All lots that contain XXX-705-XX or XXX-706-XX, where X is any number;

14) All lots that contain XXX-706-XX, where X is any number;

15) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;

16) All lots that contain XXX-706-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;

17) All lots that contain XXX-706-XX, where X is any number;

18) All lots that contain XXX-705-XX, where X is any number;

19) All lots that contain XXX-705-XX, where X is any number;

20) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;

21) All lots that contain XXX-705-XX, XXX-520A-XX, or XXX-520B-XX, where X is any number;

22) All lots that contain XXX-705-XX, where X is any number;

23) All lots that contain XXX-705-XX, where X is any number;

24) All lots that contain XXX-520-XX, XXX-520A-XX, XXX-520B-XX, or XXX-520C-XX, where X is any number;

25) All lots that contain XXX-705-XX, where X is any number;

26) All lots that contain XXX-705-XX, where X is any number;

27) All lots that contain XXX-706-XX, where X is any number;

28) All lots that contain XXX-706-XX, where X is any number;

29) All lots that contain XXX-705-XX, or XXX-779-XX, where X is any number

RECALLING FIRM/MANUFACTURER

Atlas Operations, Inc., Pompano Beach, FL,

REASON

Marketed Without An Approved NDA/ANDA: Atlas Operations is recalling 29 products sold as dietary supplements because FDA laboratory analysis revealed the presence of an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved new drugs.

VOLUME OF PRODUCT IN COMMERCE

307,993 blisters, pouches, and bottles

DISTRIBUTION

Nationwide, UK, and Sweden

PRODUCT

1) Oral Saline Laxative (Dibasic sodium phosphate 2.7g/Monobasic sodium phosphate 7.2 g) Ginger Lemon Flavor for relief of occasional constipation, Sugar Free, 1.5 Fl oz (45 mL) bottle, OTC; Product was distributed under the following labels: 1) Best Choice, UPC 0 70038 61131 8; 2) Western Family, UPC 0 15400 12193 4; 3) QC Quality Choice; (CDMA), UPC 6 35515 95528 8; 4) Rite Aid, UPC 0 11822 04105 8; 5) Safeway, UPC 3 21130 78218 6; 6) Select Brand, UPC 0 15127 01713 8; 7) Sunmark, UPC 0 10939 00744 5; 8) American Fare, UPC 0 72000 15068 9; 9) Kroger, UPC 0 41260 33384 2; 10) Major, UPC 3 09045 66675 3; 11) McKesson Medi-Pak Performance, NDC 68599-1051-1; 12) Meijer, UPC 7 19283 51548 3; 13) Premier Value, UPC 8 40986 02005 6; 14) Publix, UPC 0 41415 25073 4; 15) Healthy Accents, UPC 7 25439 93539 5; 16) Good Neighbor Pharmacy, UPC 0 87701 40136 7; 17) GoodSense, UPC 8 46036 00060 3; 18) Hannaford, UPC 0 41268 15052 6; 19) DR duane reade, UPC 6 39194 02335 1; 20) CVS Pharmacy, UPC 0 50428 08445 8; 21) Drug Mart, UPC 0 93351 12193 7; 22) Walgreens, UPC 3 11917 09279 9; 23) Longs, UPC 3 12333 00054 2; 24) The Medicine Shoppe, UPC 0 91899 18213 7; 25) LEADER, UPC 0 96295 11366 2; 26) Relieve, UPC 7 37513 30009 8; 27) TopCare: UPC 0 36800 08904 4; 28) equaline, UPC 0 41163 43255 0; 29) Today's Health, UPC 8 43072 00337 7. 30); CareOne, UPC 341520 31370 7.

2) Oral Saline Laxative (Dibasic sodium phosphate 2.7g/Monobasic sodium phosphate 7.2 g), Unflavored for relief of occasional constipation, Sugar Free, 1.5 Fl oz (45 mL) bottle, OTC; Product was distributed under the following labels: 1) QC Quality Choice; UPC 6 35515 95709 1. 2) Rite Aid; UPC 0 11822 06521 4. 3) Leader; UPC 0 96295 11444 7.

3) Oral Saline Laxative (Dibasic sodium phosphate 2.7g and Monobasic sodium phosphate 7.2 g), Cherry Flavor for relief of occasional constipation, Sugar Free, 1.5 FL OZ (45 mL) bottle, OTC; Product was distributed under the following labels: 1) Premier Value; UPC 8 40986 02238 8. 2) Good Neighbor Pharmacy; UPC 0 87701 40293 7. 3) CVS pharmacy; UPC 0 50428 09254 5. 4) Drug mart; UPC 0 93351 12204 0. 5) Walgreens; UPC 3 11917 08498 5.

4) Oral Saline Laxative (Monobasic Sodium Phosphate 2.4 g, Dibasic sodium Phosphate 0.9 g), Lemon Flavor for relief of occasional constipation, Sugar Free, Multi-Dose Container, 3 Fl oz (90 mL) bottle, OTC, Product was distributed under the following labels: 1) Walgreens, Wal-Phosphate, UPC 3 11917 05649 4; 2) Preferred plus Pharmacy; UPC 737513 00156 8.

CODE

1) Lot numbers: GL70001, GL70002, GL70003, GL70009, GL70010, GL70011, GL70016, GL70019, GL70023, GL70028, GL70030, GL70031, GL70032, GL70033, GL70038, GL70041, GL70042, GL70046, GL70052, GL70053, GL70054, GL70055, GL70058, GL70059, GL70062, GL70063, GL70064, GL70065, GL70066, GL70067, GL70070, GL70071, GL70072, GL70073, GL70074, GL70076, GL70077, GL70082, GL70083, GL70084, GL70092, GL70093, GL70094, GL70099, GL70100, GL70101, GL70102, GL70103, GL70104, GL70107, GL70108, GL70109, GL70110, GL70111, GL70112, GL70114 GL70115, GL70117, GL70118, GL70119, GL80001, GL80002, GL80003, GL80004, GL80005, GL80006, GL80007, GL80008, GL80012, GL80013, GL80014, GL80018, GL80019, GL80020, GL80021, GL80022, GL80023, GL80024, GL80026, GL80027, GL80028, GL80029, GL80030, GL80032, GL80033, GL80034, GL80035, GL80036, GL80037, GL80039, GL80042, GL80044, GL80045, GL80046, GL80048, GL80049 GL80050, GL80051, GL80052, GL80053, GL80055, GL80056, GL80058, GL80059 GL80061, GL80062, GL80063, GL80064, GL80065, GL80067, GL80068, GL80069 GL80070, GL80071, GL80072, GL80073;

2) Lot numbers: UF70015, UF70021, UF70022, UF70024, UF70025, UF70029, UF70034, UF70035, UF70047, UF70097, UF70113, UF80010, UF80040, UF80043, UF80060;

3) Lot numbers: CF70013, CF70036, CF70037, CF70045, CF70048, CF70060, CF70080, CF70086, CF70087, CF70091, CF70096, CF70105, CF80009, CF80011, CF80015, CF80016, CF80017, CF80025, CF80031, CF80038, CF80047, CF80054, CF80057, CF80066

4) Lot numbers: LE70012, LE70018, LE70026, LE70027, LE70039, LE70043, LE70049, LE70051, LE70056, LE70057, LE70061, LE70068, LE70069, LE70075, LE70079, LE70089, LE70090, LE70106

RECALLING FIRM/MANUFACTURER

Perrigo Florida Inc., Lake Worth, FL,

REASON

Label Mix-up: the product label insert mentions one of the uses as bowel cleansing, but products are not recommended for bowel cleansing.

VOLUME OF PRODUCT IN COMMERCE

103,811 Cases

DISTRIBUTION

Nationwide

PRODUCT Dacarbazine for Injection, USP; 200 mg per 20 ml vial; 10 vials per package; Rx Only. NDC for individual vials is 0703-5075-01 and 0703-5075-03 for package of ten.

CODE

Lot numbers: 31310439B exp 12/12, 08A622 exp 1/11, 31301567B exp 4/11, 31310475B exp 12/12, 31310096B exp 11/12, 31305393D exp 1/12, and 31311155B exp 2/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,

Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA.

REASON

Product may exhibit discoloration.

VOLUME OF PRODUCT IN COMMERCE

6700 vials

DISTRIBUTION

AL, CA, FL, GA, IL, PA, TN, and TX

PRODUCT

1) Methimazole USP; Tablets; 5 mg; 100 tablets: 10 blister cards of 10 tablets each packed in an outer carton; Rx Only; NDC #68084-275-01.

2) Methimazole USP; Tablets; 10 mg; 100 tablets: 10 blister cards of 10 tablets each packed in an outer carton; NDC #68084-276-01.

CODE

1) Lot 082861, Exp. 12/09; Lot 090243, Exp. 07/10; Lot 084206, Exp. 07/10; and Lot 091657, Exp. 05/10;

2) Lot 082862, Exp. 12/09; Lot 090974, Exp. 04/10; and Lot 091270, Exp. 04/10

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Health Packaging, Columbus, OH,

Manufacturer: Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI.

REASON Impurities/Degradation products. The product failed 18 month stability testing.

VOLUME OF PRODUCT IN COMMERCE

3,123 cartons of 100 tablets each

DISTRIBUTION

Nationwide

PRODUCT

Motrin IB (Ibuprofen) Tablets USP 200 mg, 100 count bottle, OTC, NDC 50580-109-04, UPC 3 0045 0463 04 3.

2) Motrin IB (Ibuprofen) Caplets, USP 200 mg, a) 24 count bottle, NDC 50580-110-03, UPC 3 0045 0481 030; b) Bonus pack (50+ 25) count bottle, NDC 50580-110-76, UPC 3 0045 0481 764; OTC.

3) Benadryl (Diphenhydramine HCl) Allergy tablets, 25 mg each, 100 Ultratab bottle, OTC, NDC 50580-226-10; UPC 3 12547 17033 8.

4) Tylenol (Acetaminophen) Tablets, Extra Strength, 500 mg Each, Easy to Swallow EZ Tabs, a) 50 count bottle, NDC 50580-422-50, UPC 3 00450422507; b) 225 count NDC 50580-422-37, UPC 3 00450422378, OTC.

5) Children's Tylenol (Acetaminophen) Tablets, Meltaways, Bubblegum Burst flavor, 80 mg, 30 count bottle, OTC, NDC 50580-519-30, UPC 3-0045-0519-306.

6) Tylenol (Acetaminophen) Caplets, Extra Strength, 500 mg each a) 24 count bottle, NDC 50580-710-24, UPC 3 0045-0444-240, b) 24+12 count bottle, NDC 50580-449-31, UPC 3 0045-0444-318, c) 50 count bottle, NDC 50580-449-06, UPC 3 0045-0444-530, d) 50 count bottle, This Package for Households Without Young Children, NDC 50580-449-07, UPC 3 0045-0449-07 8, OTC.

7) Tylenol (Acetaminophen) Capsules, Extra Strength, Rapid Release, 500 mg each, a) 225 count, NDC 50580-488-25, UPC 3 0045 0488 251, b) 24 count, NDC, 50580-488-24, UPC 3 0045 0488 244), OTC.

8) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Caplets, Extra Strength, 500mg/25 mg, a) 24 count bottle, NDC 50580-482-24, UPC 3 0045-0482-242, b) Day & Night Value Pack, 50 count bottle, NDC 50580-527-10, UPC 3 0045-0527-103, OTC.

9) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Geltab, Extra Strength, 500 mg/25 mg, 50 count bottle, OTC.

10) Tylenol PM (Acetaminophen/Diphenhydramine HCl) Gelcaps, Extra Strength, Rapid Release, 500 mg/25 mg, 20 count, OTC, NDC 50580-244-20, UPC 3 0045-0244-208.

CODE

1) Lot Number: AFA060, Exp. Date: 4/30/2012;

2) a) Lot number: ACA003 Exp. Date: 11/30/2011 b) Lot number: ACA002 Exp. Date: 9/30/2011;

3) a) Lot number: ABA567 Exp. Date: 12/31/2010 b) Lot number: ABA574 Exp. Date: 10/31/2010;

4) a) Lot number: ABA005 Exp. Date: 11/30/2010 b) Lot number: ASA206 Exp. Date: 10/31/2011;

5) Lot number: ABA544, Exp. Date: 11/30/2010;

6) a) Lot number: ABA 566, Exp, Date: 11/30/2010, b) Lot number: ACA025, Exp. Date: 12/31/2012, c) Lot number: AFA018, Exp. Date: 4/30/2013, d) Lot number: ABA168, Exp. Date: 11/30/2012;

7) a) Lot number: AJA119, Exp, Date: 6/30/2011 b) Lot number: ACA024, Exp. Date: 12/31/2010;

8) Lot number: ACA005, Exp. Date: 1/31/2011, Lot number: ADA259, Exp. Date: 2/28/2011, Lot number: AEC005, Exp. Date: 1/31/2011, Lot number: AFC005, Exp. Date: 11/30/2010, Lot number: ADC002, Exp. Date: 10/31/2010;

9) Lot number: AFA100, Exp. Date: 4/30/2011;

10) Lot number: ACA004, Exp. Date: 12/31/2010

RECALLING FIRM/MANUFACTURER

Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA,

Manufacturer: McNeil Healthcare, LLC, Las Piedras, PR.

REASON

Chemical Contamination: presence of a chemical called 2,4,6-tribromoanisole (TBA) in products.

VOLUME OF PRODUCT IN COMMERCE

2.468,496 bottles

DISTRIBUTION

Nationwide, Caribbean locations including Trinidad& Tobago, Dominican Republic, Jamaica, Fiji and Guatemal

PRODUCT

1) Benadryl (Diphenhydramine HCl) Allergy Ultratabs, 25 mg each, 100 Ultratab bottle, OTC.

2) Tylenol Extra Strength Rapid Release Gels (Acetaminophen), 24 and 225 count bottles.

CODE

1) Lot # AJA008, ABA022, ABA264, ADA194;

2) Lot # ASA202 Expiration date 10/2011

RECALLING FIRM/MANUFACTURER

McNeil Consumer Products Co., Fort Washington, PA,

REASON

Chemical contamination: presence of a chemical called 2,4,6,-tribromoanisole.

VOLUME OF PRODUCT IN COMMERCE

1) 333,288 bottles; 2) 132,120 bottles

DISTRIBUTION

Nationwide, Bermuda, Trinidad and Tobago

PRODUCT

1) Methimazole, USP; 5 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; NDC 57664-458-88 (100 count), NDC 57664-458-18 (1000 count).

2) Methimazole, USP; 10 mg tablets; 100 or 1000 tablets per bottle (some bulk); Rx; NDC 57664-459-88 (100 count), NDC 57664-459-18 (1000 count).

CODE

1) All lots shipped prior to 6/24/09: 100 count lots: 80008A, 80009A, 81430B, 81431A, 81583B, 81584A, 82294A, 82295A, 82296B, 82297B, 82568A, 82569A, 82570A, 90311A, 90312A, 90313A, 90315A, 90656A, 90657A, 90658A, 90659A and 90660A. 1000 count lots: 80009B, 80010A, 80011A, 81093A, 82296A, 82297A, 82571B and 90314A;

2) All lots shipped prior to 6/24/09: 100 count lots: 80012A, 80013A, 81717A, 81718B, 82070A, 82073A, 82566A, 82567A and 90385A. 1000 count lots: 80013B, 80014A, 82071A, 82072A and 90384A

RECALLING FIRM/MANUFACTURER

Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI,

REASON

Impurities/Degradation products. The product failed 18 month stability testing.

VOLUME OF PRODUCT IN COMMERCE

89,032 5 mg bottles; 37,454 10 mg bottles

DISTRIBUTION

Nationwide

PRODUCT

VICKS Sinex (Phenylephrine HCl 0.5%) Spray, Nasal Decongestant, FL OZ (14.7 ml) bottle, OTC; The product was distributed under the following labels: 1) VICKS Sinex VapoSpray, 4 HOUR DECONGESTANT; NDC: 37000-684-01, UPC: 3 23900 00082 7. 2) VICKS Sinex NASAL SPRAY, For Sinus Relief, NDC: 37000-540-05, UPC: 3 23900 00082 7. 3) VICKS Sinex ULTRA FINE MIST, For Sinus Relief, NDC: 37000-541-05, UPC: 3 23900 00085 8.

CODE

Shipper Case code/ Bottle-Carton Code/ Expiration date: 01171720K1, 0117PR, Mar-13; 00601720K1, 0060PR, Jan-13; 00571720K1, 0057PR, Jan-13; 00511720K1, 0051PR, Jan-13; 00461720K1, 0046PR, Jan-13; 93271720K1, 9327PR, Oct-12; 93151720K1, 9315PR, Oct-12; 92921720K1, 9292PR, Sep-12; 92901720K1, 9290PR, Sep-12; 92721720K1, 9272PR, Aug-12; 92611720K1, 9261PR, Aug-12; 92601720K1, 9260PR, Aug-12; 92591720K1, 9259PR, Aug-12; 92311720K1, 9231PR, Jul-12; 92271720K1, 9227PR, Jul-12; 92261720K1, 9226PR, Jul-12; 92081720K1, 9208PR, Jun-12; 91821720K1, 9182PR, Jun-12; 91801720K1, 9180PR, May-12; 91601720K1, 9160PR, May-12; 91381720K1, 9138PR, Apr-12; 90781720K1, 9078PR, Feb-12; 90761720K1, 9076PR, Feb-12; 90491720K1, 9049PR, Jan-12;; 90481720K1, 9048PR, Jan-12; 90191720K1, 9019PR, Jan-12; 83241720K, 8324PR, Oct-11; 83231720K1, 8323PR, Oct-11; 83181720K1, 8318PR, Oct-11; 82941720K1, 8294PR, Sep-11; 82911720K1, 8291PR, Sep-11; 82521720K1, 8252PR, Aug-11; 82491720K1, 8249PR, Aug-11; 82481720K1, 8248PR, Aug-11; 82241720K1, 8224PR, Jul-11; 82011720K1, 8201PR, Jun-11; 82001720K1, 8200PR, Jun-11; 81991720K2, 8199PR, Jun-11; 81851720K2, 8185PR, Jun-11; 81851720K1, 8185PR, Jun-11; 81431720K1, 8143PR, Apr-11; 81421720K1, 8142PR, Apr-11; 80771720K1, 8077PR, Feb-11; 73371720K1, 7337PR, Nov-10; 73161720K1, 7316PR, Oct-10; 73061720K1, 7306PR, Oct-10; 72911720K1, 7291PR, Sep-10; 72841720K1, 7284PR, Sep-10; 72601720K1, 7260PR, Aug-10; 72561720K1, 7256PR, Aug-10; 72281720K2, 7228PR, Jul-10; 72231720K1, 7223PR, Jul-10; 72221720K1, 7222PR, Jul-10

RECALLING FIRM/MANUFACTURER

Recalling Firm: Procter & Gamble Co, Mason, OH

Manufacturer: Olay LLC, Cayey, PR.

REASON

Stability Data does not Support Expiration Date/Presence of Precipitate: The product formulation may not meet the expiration dates on the package and found evidence of a chlorhexidien precipitate.

VOLUME OF PRODUCT IN COMMERCE

3.09 million bottles

DISTRIBUTION

Nationwide

PRODUCT

ShopKo Cold/Flu Relief Multi Symptom Night Time Original (Acetaminophen 500mg, Dextromethorphan HBr 15mg, Doxylamine Succinate 6.25mg per 15mL tablespoon); liquid; 10 ounce bottle; UPC: 40064536093; Product Code 2415; OTC.

CODE Lot # 4134

RECALLING FIRM/MANUFACTURER

IGI Inc., Buena, NJ,

REASON

Superpotency for Doxylamine Succinate during stability testing.

VOLUME OF PRODUCT IN COMMERCE

732 bottles

DISTRIBUTION

Nationwide

PRODUCT

ACUVAIL (Ketorolac tromethamine) 0.45% Ophthalmic solution, 0.4 mL Vial, Rx only, 1) 5 Single-Use Vials 0.4 mL Each, UPC 3 00233 50705 6; 2) 30 Single-Use Vials 0.4 mL Each, UPC 3 00233 50730 8, NDC 0023-3507-30.

CODE

Lot numbers 62348, 62377, 62385, 62386, 62391, 62438, 62815, 63191, 64040

RECALLING FIRM/MANUFACTURER

Recalling Firm: Allergan Inc., Irvine, CA,

Manufacturer: Allergan Sales, LLC, Waco, TX.

REASON

Failed PH Specifications: some lots found to be pH out of specification.

VOLUME OF PRODUCT IN COMMERCE

5,784,792 Unit Dose Vials

DISTRIBUTION

Nationwide

Novacare LLC Conducts Recall of Products Found to Contain Undeclared Drug Ingredient

Novacare LLC is recalling products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

The products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction.

The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being recalled.

Consumers should return any unused product to the place of purchase or contact Novacare LLC directly at 801-290-1738, Monday – Friday, 10 am to 4 pm MDT.

WEEK ENDING AUGUST 7

EZVille, Ltd. Issues a Recall of Solo Slim® Found to Contain an Undeclared Drug Ingredient

EZVille, Ltd. of Ronkonkoma, NY, is recalling Solo Slim® because lab analysis found it contained an undeclared drug ingredient. Solo Slim® was found to contain Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Solo Slim®, therefore the safety and effectiveness of the product is unknown.

EZVille, Ltd. has decided to recall Solo Slim® and Solo Slim® Extra Strength products, both marketed as dietary supplements for weight loss. Solo Slim® is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00206 9. Solo Slim® Extra Strength is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00220 5. All lots of these products with expiration dates including and prior to August 2013 currently available on the market are being recalled. The products were sold to distributors and retail stores nationwide and via internet sales.

Consumers should not consume Solo Slim® and Solo Slim® Extra Strength, and should return them immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking these products.

Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

EZVille, Ltd. Issues a Recall of Revivexxx® Extra Strength Found to Contain an Undeclared Drug Ingredient

EZVille, Ltd. of Ronkonkoma, NY, is recalling Revivexxx® Extra Strength because lab analysis found undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

Revivexxx® Extra Strength is marketed as a dietary supplement sexual enhancer for men. Revivexxx® Extra Strength is packaged in a single dose blister pack containing one oral tablet and bears UPC 8 35470 00207 9. All lots of this product with expiration dates including and prior to August 2013 currently available on the market are being recalled. The product was sold to distributors and retail stores nationwide and via internet sales.

Consumers should not consume Revivexxx® Extra Strength and should return it immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking this product.

Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

PRODUCT

1) Amoxicillin for Oral Suspension, USP, 400 mg/5 mL, 100 mL (when reconstituted) bottle, Rx only; NDC 0093-4161-73.

2) Amoxicillin and Clavulanate Potassium For Oral Suspension USP, 600 mg/42.9 mg per 5 mL, 75 mL (when reconstituted) bottle, Rx only; NDC 0093-8675-78.

3) Penicillin V Potassium for Oral Suspension, USP, 250 mg (400,000 U) per 5 mL, 100 mL (when reconstituted) bottle, Rx only; NDC 0093-4127-73.

CODE

1) Lot 35409398A, Exp 07/10; Lot 35410920A, Exp 11/10; Lot 35411610B, Exp 01/11;

2) Lot 35412741A, Exp 06/10;

3) Lot 418824A, Exp 06/10

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,

Manufacturer: Novopharm Limited, Ontario, Canada.

REASON

Subpotent (Single Ingredient) Drug: Some bottles may not meet fill weight specifications.

VOLUME OF PRODUCT IN COMMERCE

131,882 bottles

DISTRIBUTION

Nationwide

PRODUCT

Oxygen, Compressed, USP in M6 and E cylinders.

CODE

All codes before 042010

RECALLING FIRM/MANUFACTURER

Jayhawk Pharmacy and Patient Supply, Topeka, KS,

REASON Lack of conformance with GMP's (including but limited to failure to perform assay testing on each manifold filling sequence, failure to properly calibrate gas analyzer).

VOLUME OF PRODUCT IN COMMERCE

Approximately 580 cylinders

DISTRIBUTION KS

PRODUCT

Wellbutrin XL (buproprion Hydrochloride Extended Release Tablets) 150 mg, 90 tablets,

NDC: 64455-730-90.

CODE Lot number 10C094P, Exp July 2011

RECALLING FIRM/MANUFACTURER

Recalling Firm: BTA Pharmaceuticals Inc., Bridgewater, NJ,

Manufacturer: Biovail Corp., Manitoba, Canada.

REASON Wellbutrin XL, 150 mg extended release tablets are being recalled because the dissolution release rate is below specification for two tablets at the four hour time point.

VOLUME OF PRODUCT IN COMMERCE

12,981 bottles of 90 count

DISTRIBUTION

Nationwide

PRODUCT Sani Pads, 100 Pre-Moistened Hemorrhoidal/Vaginal Pads. Also packaged as Rexall Hygienic Cleansing Pads, 50 Count; Manufactured for: Rexall Brands; and Publix Hygienic Cleansing Pads, 100 count. 100 count NDC 0713-0308-98; 50 Count NDC # 0713-0308-42.

CODE Lot # 030808020, Exp 9/2010

RECALLING FIRM/MANUFACTURER

G & W Laboratories, Inc., South Plainfield, NJ,

REASON Product Lacks Stability: The 18 month room temperature stability alcohol assay value failed to meet specifications.

VOLUME OF PRODUCT IN COMMERCE

7,872 jars of 100, 2,976 jars of 50

DISTRIBUTION

Nationwide and Canada