APRIL 2010

PRODUCT
1) MASS TABS capsules, Proprietary Mass Tabs Blend (Kudzo Extract 40%, Trifolium Pratense Extract 8%, Fenugreek Seed Powder, Tibulus Terrestris Extract 40%, MethylSten (17-beta-hydroxy-2-alpha, 17-dimethyl-5-alpha-androstan-3-one azine), Avena Sativa Extract 10:1, Pygeum africanum Bark Extract 4:1, Milk Thistle, Maca Powder Extract .6%, Epidmedium Leaf, Bacopa Monniera Extract 4:1, Rhodiola Rosea 3%, Nettle Leaf Powder) 87,000 mcg, 30-count bottles and 60-count bottles; UPC 6 75941 00149 4.

2) RIPPED TABS TR tablets, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 425 mg, Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6(3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestris (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnatine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 234 mg, 60-count Foil Packed Tablets in a box, UPC 6 75941 00162 3.

3) DUAL ACTION GROW TABS capsules, Proprietary Testopen Blend (Kudzu root, Green Tea, zinc aspartate, Pygeum africanum extract, Stinging nettle leaf extract, 17 alpha methyl 17 beta hydroxyl 5 alpha androst 2 ene, 4 Androstene 4 chloro 17 alpha methyl 3 beta 17 beta diol, Urtica Dioca, Tongkat Ali (Malaysian Eurycoma Longifolia Jack), Dodder Seed) 250 mg, Bergamottin 50 mg, Bupleurum 50 mg, Hoelen 50 mg, 60-count foil packed 582 mg capsules in a box, UPC 6 75941 00252 1.

4) BROMODROL tablets, Bromodrol Growth Complex [Green Tea (Polyphenols), Hoelene, Bergamottin, Bupleurum, 6 Bromo 3, 17 dioxoetioallochalane, Nettle Root, Chrysin, Saw Palmetto, Schizandra Berry, Wild Yam, Safed Musli] 531 mg, 60-count foil packed in a box, UPC 6 75941 00250 7.

5) RIPPED TABS TR capsules, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 500 mg, anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6(3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestria (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnitine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 257 mg, 60-count bottle, UPC 675941001623.
CODE
1) All lots purchased during or after 4/09, Lot # 1022, 0205, and 81509;
2) All lots purchased during or after 12/08, Lot #: CW-20, CY-64;
3) All Lots, CW-68, DA-90;
4) All lots, CU32;
5) All lots, Lot 6597010
RECALLING FIRM/MANUFACTURER
Recalling Firm: IDS Sports, Oviedo, FL,
Manufacturer: Innovative Health Products, Inc, Div. Dynamic Health Prod., Largo, FL; Redefine Nutrition, Suwanee, GA. REASON Marketed Without An NDA/ANDA: product contains undeclared steroids or steroid-like substances, making them unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE 32,340 boxes and bottles
DISTRIBUTION Nationwide, Brazil, Denmark, India, Lebanon, UAE, and United Kingdom

PRODUCT
1) PAI YOU GUO Slim Capsule, 30-count box, Produce: A Medicine Industry Group Company.

2) PAI YOU GUO, 10 g tea packs individually packaged in a pouch, 18-count pouches per box, Produce: A Medicine Industry Group Company.
CODE
1) and 2) All product shipped between 04/01/2009-09/30/2009;
RECALLING FIRM/MANUFACTURER
Recalling Firm: GMP Herbal Products, Inc., Westminster, CA,
Manufacturer: Zhejiang Camel Transworld, Hangzhou, China. REASON Marketed Without An Approved NDA/ANDA: The recall was initiated because PAI YOU GUO, a weight loss dietary supplement, sold and marketed by the firm was found to contains undeclared drug ingredients.
VOLUME OF PRODUCT IN COMMERCE Approximately 100 boxes
DISTRIBUTION Nationwide

PRODUCT ROCK HARD WEEKEND capsules, 1 capsule per blister card (UPC 0 94922 14725 7), 3-count bottle (UPC 0 94922 20870 5), and 8-count bottle (UPC 0 94922 14724 0), Made in the USA.
CODE
Blister Pack Lot T12 705 08 (Exp: 10/11); Lot T12 705 09 (Exp: 03/12, 08/12); 3-ct Bottle (UPC 0 94922 20870 5): R417 0509 (Exp: 09/12); 8-ct Bottle (UPC 0 94922 14724 0): T237 0509 (Exp: 06/12)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rock Hard Laboratories, Roswell, GA,
Manufacturer: Atlas Operations, Inc., Pompano Beach, FL.
REASON Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug because the product contains sulfoaildenfil.
VOLUME OF PRODUCT IN COMMERCE 250,000 capsules (blisters and bottles)
DISTRIBUTION Nationwide, Albania, Aruba, Australia, Brazil, Canada, Denmark, Finland, Greece, Ireland, Netherlands, Peru, Portugal, South Africa, Spain and the UK

PRODUCT Metoprolol Tartrate Tablets, USP, 50 mg, 1000 count bottles, Rx only. NDC 63304-580-10.
CODE Lot #: CGR9009AC, exp 05/11
RECALLING FIRM/MANUFACTURER
Ipca Laboratories Limited, Silvasa (D and NH), India
REASON Tablet thickness: Metoprolol tablets may be out of specification for tablet thickness.
VOLUME OF PRODUCT IN COMMERCE 1,941 bottles
DISTRIBUTION Nationwide

PRODUCT ST. JOSEPH SAFETY COATED ASPIRIN (aspirin) enteric coated tablet, 81 mg, a) 36-count bottle, NDC 50580-126-36, UPC 3 0045012636 8; b) 100-count bottle, NDC 50580-126-10, UPC 3 0045012610 8; c) 180-count bottle, NDC 50580-126-18, UPC 300450126184 d) 300- count bottle, NDC 50580-126-03, UPC 30045012630; OTC.

2) ST. JOSEPH CHEWABLE ASPRIN (aspirin) orange flavored chewable tablet, 81 mg, a) 36-count bottle, NDC 50580-173-36, UPC 300450173362 b) 3x36- count bottle, NDA 50580-173-08, UPC 300450173089; OTC. CODE
1) a) Lot # AFM026, AHM327, Exp 04/30/2011; AHM432, Exp 06/30/2011; AJM321, ALM327, Exp 07/31/2011; AMM324, Exp 08/31/2011; APM349, and APM420 Exp 10/31/2011; b) Lot #.AEM050, Exp 03/31/2011; AHM374, Exp 06/30/2011; AJM320, AJM402, Exp 07/31/2011; ALM341, AMM365, Exp 08/31/2011; AMM366, AMM367, Exp 09/30/2011; APM350, and APM351, Exp 10/31/2011; c) Lot #..AMM323, AMM433, Exp 08/31/2011; and APM304, Exp 09/30/2011; d) Lots #: AHM368, ALM377, Exp 06/30/2011; ALM378, AMM354, Exp 08/31/2011; and APM427, Exp 09/30/2011;

2) a) Lot # APM440, Exp 06/30/2011; AMM325, Exp 09/30/2011; and APM430, Exp 10/31/2011; b) AFM360, AHM423, Exp 06/30/2011; ALM346, Exp 08/31/2011; and AMM434, Exp 09/30/2011
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA,
REASON Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE 4,032,160 Bottles
DISTRIBUTION Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT Digoxin Tablets, USP, 125 mcg (0.125 mg), 1000 count bottle Rx only; NDC 0143-1240-10.
CODE Lot # 66873A, Exp 5/2011
RECALLING FIRM/MANUFACTURER
West-ward Pharmaceutical Corp., Eatontown, NJ,
REASON Superpotent (Single Ingredient Drug): West-Ward received a complaint from a pharmacist stating that some tablets of Digoxin in a bottle of 1000 tablets were thicker than others.
VOLUME OF PRODUCT IN COMMERCE 3,894 bottles
DISTRIBUTION Nationwide

PRODUCT Cleviprex (clevidipine butyrate) injectable emulsion (0.5 mg/mL); 25 mg/50 mL single use vials (NDC 65293-002-50) packaged in a 10-count carton (NDC 65293-002-55); 50 mg/100 mL single use vials (NDC 65293-002-00) packaged in a 10-count carton (NDC 65293-002-11); Rx only.
CODE
Lot #: 68-407-DJ, Exp 08/10; 68-408-DJ, Exp 08/11; 71-101-DJ and 71-106-DJ, Exp 11/11
RECALLING FIRM/MANUFACTURER
The Medicines Company, Parsippany, NJ,
REASON Presence of Particulate Matter: The firm is expanding the recall of Cleviprex to include four additional lots due to the potential presence of stainless steel particulates.
VOLUME OF PRODUCT IN COMMERCE 4,671 cartons
DISTRIBUTION Nationwide

PRODUCT
1) Ipratropium Bromide Nasal Solution, 0.03%, 30 mL bottle, Rx only, NDC 60505-0826-1.

2) Ipratropium Bromide Nasal Solution, 0.06%, 15 mL bottle, Rx only, NDC 60505-0827-1.

3) Fluticasone Propionate USP Nasal Spray, 50 mcg per spray, 16 g net fill weight, 120 Metered Sprays per bottle, Rx Only; NDC 60505-0829-1.
CODE
1) Lot: JK0843, Exp 01/12;
2) Lot: JK0840, Exp 12/11;
3) Lot: JJ7064, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL,
Manufacturer: Apotex Inc., Richmond Hill, Ontario, Canada. REASON Presence of Foreign Substance(s): Product is being recalled due to possible contamination with metal fragments.
VOLUME OF PRODUCT IN COMMERCE 299,348 bottles
DISTRIBUTION Nationwide

PRODUCT IXEMPRA Kit (ixabepilone) for injection; 15 mg, Rx only. For intravenous infusion only. Each carton contains: 1 vial IXEMPRA (ixabepilone) for injection 15 mg; 1 vial DILUENT for IXEMPRA 8 mL; Refrigerate; NDC 0015-1910-12.
CODE Lot number 8K017C, Exp. Nov 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick ,
Manufacturer: Baxter Oncology GmbH, Halle/Westfalen, Germany. REASON Labeling Label Mix-Up: IXEMPRA vial within kits with lot number 8K017C is labeled as "Diluent for IXEMPRA for injection 8mL."
VOLUME OF PRODUCT IN COMMERCE 906 Vials
DISTRIBUTION Nationwide

PRODUCT
1) Glycopyrrolate Tablets USP, 1 mg, 100 count bottle, Rx only. NDC# 64980-131-01.

2) Glycopyrrolate Tablets USP, 2 mg, 100 count bottle, Rx only. NDC# 64980-132-01.
CODE
1) Lot # & Exp date: CPA964 12/10; 100991 5/11; 101560 6/11;

2) Lot # & Exp date: CPL7117 1/10 CPE854 5/10 CPF878 6/10 CPL823 11/10 CPA965 12/10 CPA966 12/10 101039 5/11 101540 6/11
RECALLING FIRM/MANUFACTURER
Corepharma Llc, Middlesex, NJ,
REASON Impurities/Degradation Products: An investigation had determined that some lots of Glycopyrrolate 1 mg and 2 mg Tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE 68,409 bottles
DISTRIBUTION NJ

PRODUCT Benadryl Allergy (Diphenhydramine HCL / Antihistamine), tablets, 25 mg, 148 Ultratab Tablets per bottle, NDC 505580-226-14.
CODE
Lots #'s: AAA422 Exp Date 11/30/2010, AJA094 Exp Date 5/31/2011, ABA392 Exp Date 11/30/2010, and ALA034 Exp Date 6/30/2011
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA,
Manufacturer: Mcneil Healthcare, Llc, Las Piedras, PR. REASON Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE 258,720 bottles
DISTRIBUTION Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT Simply Sleep Nightime Sleep Aid Contains Diphenhydramine HCL, caplets. 25 mg, 100 count bottle, NDC 50580-843-10.
CODE
Lots #'s: ADM015 Exp Date: 2/28/2011, ADM016 Exp Date 2/28/2011, AFM014 Exp Date 12/31/2010, AFM352 Exp Date 2/28/2011, AJM319 Exp Date 5/31/2011 , AJM364 Exp Date 7/31/2011 , ALM387 Exp Date 7/31/2011, AMM436 Exp Date 7/31/2011, and AMM438 Exp Date 10/31/2011
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: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2, 4, 6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE 1,173,744 bottles
DISTRIBUTION Nationwide, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT Tropical Breeze (Triclosan), anti-bacterial foaming soap, 18 fl. oz.
CODE Batch number 1003201
RECALLING FIRM/MANUFACTURER
Zep Manufacturer, Atlanta, GA
REASON The product will not meet its normal shelf life of two years due to the presence of spoilage organisms.
VOLUME OF PRODUCT IN COMMERCE 9,720 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Risperidone Tablets USP, 2 mg, 60-count bottle, Rx Only, NDC 5111-204-60.

2) Risperidone Tablets USP, 4 mg, 60-count bottle, Rx Only, NDC 5111-206-60.
CODE
1) Batch # C82255, C82256, C82507, Exp 4/2010;

2) Batch # C82260, C82261, C82262, C82517, Exp 4/2010; Batch # C90426, Exp 10/2010; Batch # C95500, Exp. 9/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy'S Laboratories Inc., Bridgewater, NJ,
Manufacturer: Dr. Reddy's Laboratories Limited, Anhdra Pradesh, India.
REASON Impurities/Degradation Products: Out of Specification results for impurities at the 18 month time point.
VOLUME OF PRODUCT IN COMMERCE 78,876 bottles
DISTRIBUTION Nationwide

Atlas Operations, Inc. Announces Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements

Atlas Operations, Inc. is expanding its recall of the company’s dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100.

These products were sold as dietary supplements throughout the United States. Atlas Operations, Inc. is conducting a recall after lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil. The active drug ingredient is not listed on the product label.

The recalled products are in capsule form and may be packaged in blisters, pouches or bottles. All expiration dates of the products are included in this recall.

PRODUCT	LOT NUMBER*
72 Hours (all strengths)	###-705-## ###-706-##
Amour Again for Him	###-705-##
Arousin	###-705-##
Clyamax	###-705-##
Depth Charge	###-807-## ##-807-##
Enhancement	###-705-## ###-706-##
Erectzia	###-705-## ##-705-##
Erexa	###-705-##
Ere-xxx by Elite Body	###-705-## ##-705-##
Ere-xxx by Maxi Elit	###-705-##
Erousa	###-705-##
Ezerex	###-705-## ###-706-##
Finally On Demand	###-706-##
Libiplus	###-705-## ###-520A-## ###-520B-##
Love Fuel	###-706-## ###-520A-## ###-520B-##
Rainbow Rocket	###-706-##
Red Hot Sex	###-705-##
Sexual Surge	###-705-##
Stamin It	###-705-## ###-520A-## ###-520B-##
Staminil	###-705-## ###-520A-## ###-520B-##
Tacktol	###-705-##
Topviril	###-705-##
Vaxitrol	###-520-## ###-520A-## ###-520B-## ###-520C-##
Vierect	###-705-##
Vigor 100	###-705-##
Whatz Up Rx	###-706-##
Xtremexcite	###-706-##
Zenerect	###-705-## ###-779-##

*Consumers can identify recalled products by the 3 or 4 digit code located in the middle of the lot numbers noted above, where “#” represents any alphanumeric digit. Additionally, the lot numbers may or may not contain dashes.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase. You may also return products directly to Atlas Operations.

Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am – 5:00 pm EST for instructions on the return and refund process.

PRODUCT
1) Yi Shou capsules, 400 mg, (3 x 10-count blister packs) 30 capsules per box.

2) Yi Shou Capsules, 650 mg, Extra Strength, (3 x 10-count blister packs) 30 capsules per box.
CODE All lots
RECALLING FIRM/MANUFACTURER Healthy Body Forero, Bayamon, PR,
REASON Marketed Without Approved NDA/ANDA: FDA analysis found that these products contains sibutramine, the active ingredient in an FDA-approved drug indicated for use as an appetite suppressant for weight loss, making it an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION PR

PRODUCT Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400 mg/5 mL; Rx only; NDC 63304-979-01.
CODE Lot numbers# 1910779 and 1910782 of 400mg/57mg (base) per 5mL; Exp 5/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Princeton, NJ,
Manufacturer: Ranbaxy Laboratories, Ltd., Dewas, India.
REASON Complaints received of 2 lots of Amoxicillin & Clavulanate Potassium for Oral Suspension turning brown upon reconstitution. The product should be white.
VOLUME OF PRODUCT IN COMMERCE a) 23,544; b) 11,400
DISTRIBUTION Nationwide

PRODUCT
1) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL Sterile, For IM, Intrasynovial and Soft Tissue Use. Not For Intravenous Use. Shake Well. Rx only, 1mL Single Dose Vial; NDC 0781-3131-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile for intramuscular, intrasynovial and soft tissue injection only. Not For Intravenous Use, Rx only, One 1 mL Single Dose Vial, Case label: SANDOZ; MethylPREDNISolone Ac 40 mg/mL SD 1 mLV US, Qty: 120 x (1 x 1 mL), Store between 20-25 'C; Exp: 2010-11.

2) 2) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile, For IM, Intrasynovial and Soft Tissue Use. Not For Intravenous Use. NDC 0781-3131-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile for intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use, Sterile Rx only, 10x1 mL Single Dose Vials. Case label: SANDOZ; METHYLPREDNI Ac 40 mg/mL SD 10 x 1mLV US, Qty96 x (10 x 1 mL) Store between 20-25 'C.

3) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For IM, Intrasynovial and Soft Tissue Use, Not For Intravenous Use, Shake Well, Rx only, 1mL Single Dose Vial, NDC 0781-3132-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, Sterile, For intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use, Rx only, One 1 mL Single Dose Vial, Case label: SANDOZ; METHYLPREDNI Ac 80 mg/mL SA IMV US, Qty: 120 x (1 x 1 mL), Store between 20-25 'C.

4) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For IM, Intrasynovial and Soft Tissue Use, Not For Intravenous Use, Shake Wwll, Rx only, 1mL Single Dose Vial, NDC 0781-3132-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use, Rx only, 10 x 1 mL Single Dose Vials, Case label: SANDOZ; METHYLPREDNI Ac 80 mg/mL SA IMV US, Qty: 96 x (10 x 1 mL), Store between 20-25 'C.
CODE
1 Lot numbers: 150692, exp 11/30/2010; 150693, exp. 11/30/2010 and 155905, exp. 7/31/2011;

2) Lot numbers: 149633, exp. 10/31/2010; 152864, exp. 3/31/2011; 155904, exp. 7/31/2011;

4) Lot numbers: 150568, exp. 11/30/2010; 153048, exp. 3/31/2011; 158623, exp. 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ,
Manufacturer: Sandoz Canada Inc., Boucherville, Canada.
REASON Methylprednisolone Acetate in the 40 and 80 mg, single dose lots were mistakenly labeled with a 24 month expiration date instead of 18 months.
VOLUME OF PRODUCT IN COMMERCE 35,235 vials
DISTRIBUTION Nationwide

PRODUCT Temodar (temozolomide) for Injection, 100 mg/vial, for Intravenous Use Only, Single-Use Vial, Discard after use, Rx only, NDC 0085-1381-01.
CODE Batch # E-KAS- and E-KAS-3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Corp., Miami Lakes, FL,
Manufacturer: Baxter Oncology GmbH, Halle/Westfalen, Germany.
REASON There is potential for defects to exist in the glass vials that may, in rare cases, result in damage to the vials that may compromise the integrity of the vials. Use of these vials which are damaged may present a risk of infection to patients, particularly those who are immunocompromised.
VOLUME OF PRODUCT IN COMMERCE 6,792 vials
DISTRIBUTION Nationwide

PRODUCT Fluocinonide Cream USP, 0.05%, Net Wt 30 grams, Rx only; NDC 0168-0139-30.
CODE Lot 872A (exp 9/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US Inc., Melville, NY,
Manufacturer: Nycomed Us Inc., Hicksville, NY.
REASON Firm received one complaint of leakage from tube crimp.
VOLUME OF PRODUCT IN COMMERCE 30,358 units
DISTRIBUTION Nationwide

PRODUCT Rosaderm Cleanser (Sodium Sulfacetamide 10%/Sulfur 5%), packaged in 6 oz (NDC 68032-104-06) and 12 oz tubes, NDC 68032-104-12, Rx only.
CODE
6 oz (NDC 68032-104-06) Lot #s: 15400, Exp 3/31/2010; 15600, Exp 4/30/2010; 88100, Exp 5/31/2010; 88200, Exp 5/31/2010; F08A056, Exp 10/31/2009; F08A060, Exp 10/31/2009; F08C064, Exp 12/31/2009; 12 oz (NDC 68032-104-12) Lot #s: 88000, Exp 5/31/2010; F07K075, Exp 8/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: River's Edge Pharmaceuticals, LLC, Suwannee, GA,
Manufacturer: Harmony Labs, Inc., Landis, NC.
REASON Manufacturing Validation: Packaging validation was conducted after product distribution.
VOLUME OF PRODUCT IN COMMERCE 43,655 tubes
DISTRIBUTION Nationwide

PRODUCT
1) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 4.5%, 400 mL bottle, Rx Only, NDC 68032-114-40.

2) Benzoyl Peroxide Cream, Topical Acne Therapy, 6.5%, 125 mL tube, Rx Only, NDC 68032-118-12.

3) Benzoyl Peroxide Gel, Topical Acne Therapy, 4.5%, 125 mL tube, Rx Only, NDC 68032-113-12.

4) Benzoyl Peroxide Pad, 4.5%, box containing 30 foil pouches each with a single-use medicated pad (6 mL each), Rx Only, NDC 68032-143-75.

5) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 6.5%, 400 mL bottle, Rx Only, NDC 68032-120-40.

6) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 8.5%, 400 mL bottle, Rx Only, NDC 68032-117-40.
CODE
1) Lot #s: F07L048, Exp 05/31/2009; F2800, Exp 10/31/2009;

6) Lot #s: 15300, Exp 11/30/2009; F07K016, Exp 04/30/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: River's Edge Pharmaceuticals, LLC, Suwanee, GA,
Manufacturer: Harmony Labs, Inc., Landis, NC.
REASON Product lacks stability: documents indicated potential problems with assay.
VOLUME OF PRODUCT IN COMMERCE 23,597 units
DISTRIBUTION Nationwide

Kanec USA Inc., Issues a Recall of Stud Capsule For Men Marketed as Dietary Supplements

KANEC USA INC, 5061, South State Road 7. Ste 602, Davie FL 33314, is recalling Stud Capsule For Men Lot #060607-01/060108-01 Exp 6-2013. Kanec USA Inc, is conducting this recall because a laboratory analysis of Stud Capsule Lot 060607-01/060108-01 Exp 6-2013 sample found the product to be adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction(ED). Making it an unapproved new drug.

Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Stud Capsule For Men are sold nationwide. The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal.

Consumers who have Stud Capsule For Men Lot 060607-01/060108-01 Exp 6-2010 in their possession should stop using them immediately.

The Company is advising consumers to return any unused Stud Capsule For Men, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can send unused capsule to directly to the company.

KANEC USA INC
5061 SOUTH STATE ROAD 7, U602
DAVIE FL 33314
Phone: 954-583-5840
Fax: 954-583-5885

US Oftalmi Announces Recall of the Camolyn Eye Drops Product Line, and Fisiolin Nasal Drops.
Includes All Lots of 15mL Bottles.

US Oftalmi, of Hallandale, Florida, is recalling all Over-the-Counter Eye Drops and Nasal Drops. Products are packaged in 15mL plastic bottles and were distributed nationwide to food and drug distributors for retail.

PRODUCT	LOT#	EXPIRATION DATE	UPC
CAMOLYN HOMEOPATHIC	049036 087934	05/2011 08/2009	591196 00446
CAMOLYN PLUS, NAPHAZOLINE + CHAMOMILE 15 ml.	037691 097420	03/2010 10/2010	66482 00018
CAMOLYN REFRESH 15 ml.	116636 107610	11/2009 11/2010	66482 00020
CAMOLYN-A, NAPHAZOLINE + PHENIRAMINE 15 ml	057063 058962 106606 099487	05/2009 04/2010 10/2008 09/2011	66482 00019
FISIOLIN NASAL DROPS SODIUM CHLORIDE PEDIATRIC USES 15 ml.	028659	03/2011	591196 00375

This recall is being initiated due to conditions at the manufacturing facility that cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.

The company has ceased the production, importation and distribution of the products until further notice. Consumers who may have any of these products on hand are advised to discard them immediately.

Consumers with questions may call US Oftalmi at (954) 338-6891 Monday through Friday 8AM to 4:30 PM EST.

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

Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker.

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed Nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.

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.

1) Slimbionic Capsules, 350 mg of a proprietary herbal blend, packaged in 30 count boxes.

2) One Weight Loss Pill, 990 mg of a proprietary herbal blend, packaged in 30 capsule bottles.

3) SlimDemand Capsules, with FeiHua formula, 350 mg of a proprietary herbal blend, 30 count bottles.

REASON Marketed Without an Approved NDA/ANDA: product contains undeclared Sibutramine.

DISTRIBUTION Nationwide and Switzerland, Azerbaijan, Cayman Islands, Greece, United Kingdom, Norway, Australia, Ireland, Israel, Denmark, France, Canada, Sweden, Netherlands

Lot #: 61-978-DW, 61-979-DW, and 61-980-DW, Exp 01/10; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp 08/10; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/11; and 64-453-DJ, Exp 04/11

REASON Presence of Particulate Matter: Visible particulate matter was observed in certain lots of Cleviprex 0.5 mg/mL.

PRODUCT Demser (Metyrosine) capsules, 250 mg; 100 capsules per bottle; Rx only; NDC: 25010-305-15; UPC 325010305151.

REASON Failed USP Dissolution Test Requirements. Samples have failed to meet dissolution specifications.

PRODUCT Cortamox Lotion (hydrocortisone/pramoxine HCl/chloroxylenol), in each mL: 10 mg/10 mg/1 mg, 60 mL (2 fl oz) dropper bottle, Rx Only; NDC 68032-206-02.

1) Clearasil Ultra (2% Salicylic Acid) Overnight Wash, 6.78 fl. oz (200 mL), Item 39977-00613-00; UPC 8 39977 00939 1.

2) Clearasil Ultra (2% Salicylic Acid) Acne Clearing Gel Wash, 6.78 fl. oz. (200mL), Item 39977-00939-15; UPC 8 39977 00939 2.

1) Lot numbers: 01 C9296, 02 C9296, 02 C9297, 07 C9303, 02 C9299, 03 C9299, 04 C9301, 05 C9301, 05 C9302, and 06 C9302;

REASON Product has potential for losing lot code information when unwrapped.

PRODUCT Fluocinonide Ointment USP, 0.05%, For external use only, not for ophthalmic use, a) Net Wt 15 grams (NDC 0168-0140-15); b) Net Wt 30 grams (NDC 0168-0140-30); c) Net Wt 60 grams (NDC 0168-0140-60), Rx only.

CODE a) batch 902A (exp 9/11); b) batch 982A (exp 10/11); c) batch 111B (exp 10/11

REASON Out-of specification result for a known degradant was obtained for a previous batch of Fluocinonide Ointment USP, 0.05%. The firm is recalling the three batches as a precaution.

PRODUCT Selenium Sulfide Shampoo, 2.25%, 180 mL bottle, Rx Only, NDC 68032-127-18.

CODE Lot #s: 94200, Exp 8/31/2010; F08B056, Exp 2/28/2010; F07K014, Exp 10/31/2009

REASON Product Lacks Stability: No documentation of stability for 2006 and 2007.

PRODUCT RE Pramoxine-HC (hydrocortisone/chloroxylenol/pramoxine HCl), Otic drops, 10 mg/1 mg/10 mg, 10 mL dropper bottle, Rx Only, NDC 68032-379-97.