MAY 2012

MAY 2012

WEEK ENDING MAY 26

The Menz Club, LLC Issues a Recall of V Maxx Rx due to Undeclared Sulfoaildenafil

The Menz Club, LLC is conducting a recall of V Maxx RX of the following lot numbers:

Single Count, UPC Code 2802803561, Lot Nos. 101108, 101009, 101010, 101011 , Five Count, UPC Code 0972859402, Lot Nos.: 101108, 101109, 101110, Ten Count, UPC code 0913251017, Lot Nos.: 301000, 301001

A lab analysis of V Maxx Rx Lot # 101109 distributed by The Menz Club, LLC was found to contain undeclared sulfoaidenafil. Sulfoaidenafil is an analog of sildenafil, an FDA approved prescription drug used to treat Erectile Dysfunction (ED), making V Maxx Rx, an unapproved new drug. The Menz Club is recalling the above listed lots of this product which can pose a serious risk to health. Since the product has the same formulation, additional lots are being recalled.

The affected products may have been ordered online at www.vmaxxrx.com or www.themenzclub.net and were distributed to customers and distributors nationwide. This product is marketed as a dietary supplement intended for use as a male enhancement product and is packaged in one (1) and five (5) count blister packs and ten (10) count bottles.

The Menz Club, LLC is notifying its customers and distributors by email and/or phone to return or destroy all recalled products. Any consumer having V Maxx Rx should immediately stop using it and destroy the unused product or return it to ATTN: Product Returns, The Menz Club, LLC, P. O. Box 906, Madison, MS 39110. Customers with questions may call (601) 866-6746 Monday through Friday, 9:00 AM – 4:30 PM CDT for further instructions or information with respect to the return process.

Compounded Prescription Recall

All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. We have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided since November 21, 2011.

If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.

We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.

PRODUCT Celestone brand of betamethasone Oral Solution USP, 0.6 mg/ 5 mL, supplied in 4 fluid ounce (118 mL) amber glass bottles, Rx only, NDC 0085-0942-05.

CODE LOT 9 APR, 100 EXP MAR 12; LOT 9 APR 101, EXP AUG 12; LOT 9 APR 102, EXP SEP 12; LOT 9 APR 103, EXP NOV 12; LOT 0 APR 100, EXP MAR 13; LOT 0 APR 101, EXP JUN 13; LOT 0 APR 102, EXP SEP 13; LOT 0 APR 103, EXP SEP 13

RECALLING FIRM/MANUFACTURER Merck, Inc., Kenilworth, NJ,

REASON Failed Content Uniformity Requirements; potential for dosing variability found during routine product stability testing.

VOLUME OF PRODUCT IN COMMERCE 96,033 glass bottles

DISTRIBUTION Nationwide and Puerto Rico

Moog Medical Devices Group Announces Recall Of Select Curlin Administration Sets Due To Possible Health Risk

Moog Medical Devices Group (MMDG) is irecalling certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.

The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:

REF Code (REF Codes are found in the top right hand corner of the administration set packaging):

340-4114	340-4115	340-4126	340-4128	340-4128-V	340-4130	340-4130-V	340-4133
340-4137	340-4144	340-4165	340-4166	340-4173	340-4176

Lot Numbers (Lot numbers are found in the lower right hand corner of the administration set packaging):

CF1127990	CF1134390	CF1200492	CF1202592	CF1205492	CF1208091
CF1127991	CF1134391	CF1200493	CF1204092	CF1206890	CF1208092
CF1127992	CF1133490	CF1200293	CF1204093	CF1206891
CF1129990	CF1134392	CF1200494	CF1203391	CF1205493
CF1130190	CF1134990	CF1200294	CF1204091	CF1206090
CF1130690	CF1134393	CF1201893	CF1203392	CF1206091
CF1130691	CF1135490	CF1201890	CF1203390	CF1206092
CF1130693	CF1135491	CF1201190	CF1204090	CF1208090
CF1131190	CF1135492	CF1201192	CF1204690	CF1206893
CF1131191	CF1200290	CF1202591	CF1204691	CF1207592
CF1130692	CF1200291	CF1202590	CF1205491	CF1207590
CF1132290	CF1200292	CF1201891	CF1204692	CF1207591
CF1132291	CF1200490	CF1201191	CF1205490	CF1207593
CF1133491	CF1200491	CF1201892	CF1205990	CF1209091

Direct customers and distributors will be notified of the process for obtaining replacement administration sets. Patients in a home environment, please contact your home healthcare provider or clinician for proper handling and the replacement process of your affected set(s). For additional questions, contact Moog Customer Advocacy at (800) 970-2337.

WEEK ENDING MAY 19

WEST COAST NUTRITIONALS, LTD. Issues a Recall of Products FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON due to Undeclared Tadalafil

WEST COAST NUTRITIONALS, LTD is recalling all lots of FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON capsules to the consumer level. A lab analysis of FIRMINITE distributed by West Coast Nutritionals was found to contain undeclared Tadalafil. Tadalafil is an active ingredient of an approved drug for Erectile Dysfunction (ED), making FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON unapproved new drugs. All lots of these three products contain undeclared Tadalafil which can pose a serious risk to health.

The affected products may have been ordered online at www.firminite.com , www.instanthotrodextrastrength.com , www.libidron.com , www.amazon.com and were distributed to customers and retailers nationwide and worldwide. These products are marketed as dietary supplements intended for use as a male enhancement product and are as follows:

Firminite:

Firminite is sold in two count (2 ct.), four count (4 ct.), and ten count (10 ct.) individual boxes and sold in various kits and packs including but not limited to:

Intro Pack
Tester Pack
Economy Stimulus Pack
Super Performance Pack
Super Savings Pack

Firminite is sold in black and white boxes with red and yellow lettering that states, “FIRMINITE MAXIMUM STRENGTH HIGH POTENCY MALE ENHANCEMENT”.

Libidron:

Libidron is sold in two count (2 ct.), four count (4 ct.), and ten count (10 ct.) individual boxes and sold in various kits and packs including but not limited to:

Intro Special
Tester Pack
Elite Silver Pack
Elite Gold Pack
Ultimate Performance Pack
Ultimate Savings Pack

Libidron is sold in blue and orange boxes with white lettering that states, “LIBIDRON HIGH POTENCY FORMULA”.

EXTRA STRENGTH INSTANT HOT ROD:

Extra Strength Instant Hot Rod is sold in four count (4 ct.), and ten count (10 ct.) individual boxes and sold in various kits and packs including but not limited to:

Intro Special
Tester Pack
Silver Elite Special Pack
Gold Elite Special Pack
Platinum Elite Pack
Super Savings Elite Pack

Extra Strength Instant Hot Rod is sold in black and white boxes with red and white lettering that states, “EXTRA STRENGTH INSTANT HOT ROD”.

West Coast Nutritionals is notifying its customers and retailers by email and/or phone to return all recalled products. All customers and retailers that have any of these products which are being recalled should stop using these products and return any unused products to ATTN: West Coast Nutritionals, 5670 Guhn Road, Houston, TX 77040 for a direct refund. Customers with questions can call (877) 782-6464 Mon thru Fri from 9:00 AM – 6:00 PM PST for further instructions or information with respect to the return and refund process.

PRODUCT

1) Mince Belle Dietary Supplement, 30 Capsules.

2) Perfect Men Dietary Supplement, 10 Capsules.

3) EVERLAX Dietary Supplement, 30 capsules.

4) EVER Slim Dietary Supplement, 30 capsules.

5) Herbal Drink Acai-man mangosteen Dietary Supplement, Contents 16.6 fl oz.

6) EVER SLIM Shake Mix Dietary Supplement Strawberry, Net Weight 17.6 oz.

7) EVER SLIM Shake Mix Dietary Supplement Chocolate, Net Weight 17.6 oz.

CODE

1) Lot #: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, and HPCMB/10-016;

2) Lot #: HPCPM/002;

3) Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032;

4) Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038;

5) Lot #: HPJAC/004;

6) Lot #: HPESSF/168;

7) Lot #: HPESSC/061

RECALLING FIRM/MANUFACTURER

Recalling Firm: Healthy People, Irwindale, CA,

Manufacturer: Healthy Labs S. de R. L. de C. V., Irapuato, Mexico.

REASON

Marketed Without an Approved NDA/ANDA: FDA laboratory analyses found the products to contain Sibutramine, an appetite suppressant that was withdrawn from the market in October 2010 for safety reasons, making these products unapproved new drugs.

VOLUME OF PRODUCT IN COMMERCE 771 boxes (14,251 units)

DISTRIBUTION Nationwide

PRODUCT Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection, a) 5-count multidose vials per box (NDC 45567-0060-1), b) 30-count multidose vials per box (NDC 45567-0060-2), Rx only.

CODE Lot #: 220053, Exp 06/12

RECALLING FIRM/MANUFACTURER Pharmalucence, Inc., Bedford, MA,

REASON Lack of assurance of sterility - Raw material used in the manufacture of the finished product did not meet specification for endotoxins.

VOLUME OF PRODUCT IN COMMERCE 19,140 vials

DISTRIBUTION Nationwide, Puerto Rico, Australia, and Philippines

PRODUCT

1) SYMPT-X Glutamine Powder Regular Formula (glutamine), 480 gram jar, a) Product code 2L5100: cartons of 12 jars each; b) Product code 2L5011E: single jar cartons for direct consumers only; Rx only, Made in USA; NDC 0338-9170-91.

2) SYMPT-X Glutamine Powder Regular Formula (glutamine), 15 gram packets containing 10 grams Glutamine, 60-count packets per box, Rx only, Made in USA; NDC 0338-9177-91; Product code 2L5107.

CODE

1) Lot #: 0061E9, Exp 01/12; 0093G9, Exp 03/12; 0175B0, Exp 10/12; 0123F0, Exp 01/13; 0284G0, Exp 02/13; 0197J0, Exp 05/13; 0449D1, Exp 11/13; and 0145F1, Exp 12/13;

2) Lot #: 0319G9, Exp 02/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,

Manufacturer: Garden State Nutritionals, Div. Vitaquest International, LLC, West Caldwell, NJ.

REASON

Labeling: Label w/Wrong or Incorrect EXP Date: The SYMPT-X Glutamine Powder is labeled with an incorrect expiry date, past the recommended shelf life from the date of manufacture.

VOLUME OF PRODUCT IN COMMERCE 21,870 jars, 1,613 boxes of packets

DISTRIBUTION Nationwide, Canada, and Taiwan

PRODUCT

1) Topiramate Tablets, 100 mg, a) 60-count tablets per bottle (NDC 0093-7219-06, UPC 3 0093-7219-06 4), b) 1000-count tablets per bottle (NDC 0093-7219-10, UPC 3 0093-7219-10 1), Rx only.

2) Topiramate Tablets, 50 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7540-10, UPC 3 0093-7540-10 6.

3) Topiramate Tablets, 200 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7220-10, UPC 3 0093-7220-10 7.

CODE

1) Lot #: a) 29T097, 29T098, Exp 08/13; b) 29T093, 29T094, 29T096, Exp 07/13; 29T099, Exp 08/13;

2) Lot #: 16T023, 16T024, and 16T026, Exp 03/12;

3) Lot #: 30T044, Exp 06/12; and 30T085, Exp 07/13

RECALLING FIRM/MANUFACTURER

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

Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel.

REASON Impurities/Degradation Products: The specified lots may not meet the impurity specification through expiry.

VOLUME OF PRODUCT IN COMMERCE 12,467 bottles

DISTRIBUTION Nationwide

PRODUCT Ovcon 50 (norethindrone and ethinyl estradiol) tablets, USP, 1 mg/50 mcg, a) 3-count blister cards of 28 tablets each per carton (NDC 0430-0585-45, UPC 3 0430-0585-45 9), b) 6-count blister cards of 28 tablets each per Physician's Sample carton (NDC 0430-0585-95), Rx only.

CODE Lot #: a) 506964B, Exp 05/12; 509310A, Exp 09/12; 511071A, Exp 12/12; b) 506964C, Exp 05/12

RECALLING FIRM/MANUFACTURER Warner Chilcott Company LLC, Fajardo, PR,

REASON CGMP Deviations: This recall is being initiated as part of the commitments to the response to the FDA concerns on lack of full shelf-life stability data supporting 12-months expiry date.

VOLUME OF PRODUCT IN COMMERCE a) 24,754 blister cards; b) 1,590 blister cards

DISTRIBUTION Nationwide

PRODUCT Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles.

CODE

Lot # Exp Date: F48768 02/2013; F71099 03/2013; F74724 03/2013; 42281 03/2013; 42284 03/2013; 42285 03/2013; 42288 03/2013; 42291 03/2013; 1355CB 03/2013; 1712FR 03/2013;1412RR 03/2013 ; 1612RR 03/2013; 2010KA 03/2013 ; 1362KA 03/2013; 1361KA 03/2013 ; 1712AR 03/2013; 1612AR 03/2013 ; 1112CRA 03/2013; 1812AR 03/2013; 1212CR 03/2013; 1112CR 03/2013; 2005HA 03/2013; 2053DA 03/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pfizer Inc., New York, NY,

Manufacturer: Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina. .

REASON CGMP deviation; enzymatic hydrolysis time for the gelatin manufacturing process of these lots was increased which may have caused a stronger odor of the product.

VOLUME OF PRODUCT IN COMMERCE 653,162 units

DISTRIBUTION Nationwide

PRODUCT Levonorgestrel and Ethinyl Estradiol Tablets USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets USP (0.01 mg), Rx Only, 2 X 28 Tablets and 1 X 35 Tablets per Pouch, NDC 68180-848-11 (pouch), 68180-848-13 (carton).

CODE Lot #: 118901386, Exp. 9/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, .

Manufacturer: Lupin Pharmacare Ltd., Indore Madhya Pradesh, India.

REASON Impurity/Degradation Products: This product is being recalled due to an out of specification test result for an individual unspecified impurity, identified as Bisphenol-A, during the 3 month long term stability testing.

VOLUME OF PRODUCT IN COMMERCE 5,400 cartons (10,800 pouches)

DISTRIBUTION Nationwide and PR

PRODUCT Omnaris (ciclesonide) Nasal Spray 50 mcg, 7.1 g bottle, 60 metered actuations, Professional Sample, Rx only, NDC 63402-701-02, UPC 3 63402-702-02 0.

CODE Lot # 138122, Exp 08/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sunovion Pharmaceuticals Inc., Marlborough, MA, .

Manufacturer: Nycomed GmbH (frmly: Altana), Singen (hohentwiel), Germany. .

REASON

Product Lacks Stability: Pinhole defects in the pouch surrounding the immediate container permit air ingress and results in a decrease of the preservative potassium sorbate and an increase in an associated impurity.

VOLUME OF PRODUCT IN COMMERCE 94,810 bottles

DISTRIBUTION Nationwide

Hospira Announces A Recall Of One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume

Hospira, Inc. (NYSE: HSP), is recalling one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1283-31, due to complaints of a single Carpuject containing more than the 1 mL labeled fill volume.

The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL. The expiration date is July 1, 2013.

The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

WEEK ENDING MAY 12

PRODUCT Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg, packaged in a) 30-day supply (3 blister cards x 60 tablets) 180 tablets per carton, NDC 0456-3330-60, UPC 3 0456-3330-60 5; b) 10 x 10 blister cards (100 tablets) per carton hospital unit dose, NDC 0456-3330-63, UPC 0 04563 33063 5; and c) 7-day supply (1 blister card x 42 tablets) per Patient Starter Kit, professional sample blister pack, NDC 0456-3330-42; Rx only.

CODE

Lot #: a) 1069783, Exp 04/30/12; 1079546, 1082538, Exp 01/31/13; b) 1071614, Exp 04/30/12; 1072823, Exp 10/31/12; 1077653, 1078959, Exp 01/31/13; and c) 1073308, Exp 10/31/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO,

Manufacturers: Merck Sante, Semoy, France;

Forest Pharmaceuticals Inc., Cincinnati OH.

REASON

Failed USP Dissolution Test Requirements: Failing high results for the acid-stage dissolution test was obtained at the 18-month test interval.

VOLUME OF PRODUCT IN COMMERCE 24,469 blister packs and cartons

DISTRIBUTION Nationwide and PR

PRODUCT

1) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Cherry Flavor 160 mg per 5 mL pain reliever/fever reducer a) 1 fl oz,. 30 mL UPC 011673574095, b) 2 fl oz, 60ml, UPC 011673574781, c) Twin Pack - 2 fl oz (60ml), UPC 011673574033, d) Twin Pack Promotion - 2 fl oz UPC 011673257424.

2) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Grape Flavor 160 mg per 5 mL pain reliever/fever reducer 2 fl oz. 60 mL UPC 011673602781.

CODE

1) Units: 574-3426 09/2013 574-3427 09/2013 574-3428 09/2013 574-3439 09/2013 574-3445 09/2013 574-3446 09/2013 574-3502 10/2013 574-3669 11/2013 574-3670 12/2013 574-3671 12/2013 574-3691 12/2013 574-3692 12/2013 574-3714 12/2013 574-3715 12/2013 574-3732 12/2013 374-3760 01/2014 574-3761 01/2014;

2) Unit: 602-3716 12/2013

RECALLING FIRM/MANUFACTURER Guardian Drug Co. Inc., Dayton, NJ,

REASON Mislabeling: Infant acetaminophen suspension product labeling was missing the statement "Under 2 years ask doctor" and the weight-based dosing of the label provides for doses that are higher than what has been recommended for children 2 years and older.

VOLUME OF PRODUCT IN COMMERCE 260,424 cartons

DISTRIBUTION MN

PRODUCT Lorazepam Oral Concentrate, USP, 2 mg/mL, Rx Only, 30 mL bottle, NDC 0574-0163-30.

CODE Lot #s: 2010302121, Exp 07/2012; 2010392922, Exp 09/2012; 2010514031, Exp 12/2012; 2011084759, Exp 02/2013; 2011145313, Exp 04/2013; 2011235889, Exp 06/2013

RECALLING FIRM/MANUFACTURER Paddock Laboratories, Inc., Minneapolis, MN

REASON Impurities/Degradation Products: This recall has been initiated due to non-conformance to the specification for a specified impurity (Related Compound C) at the 12-month stability test station

VOLUME OF PRODUCT IN COMMERCE 93,354 Bottles

DISTRIBUTION Nationwide

PRODUCT Losartan Potassium Tablets USP, 50 mg, 1000 film coated tablets, NDC 16714-582-03.

CODE Lot #G00921A EXP AUG 2013 Lot #G00922A EXP AUG 2013 Lot #G00923A EXP AUG 2013

RECALLING FIRM/MANUFACTURER Actavis Pharma Manufacturing Private Limited, Kanchipuram, India,

REASON Presence of Foreign Substance; magnesium stearate excipient used in the product was found to be contaminated with zeolite, calcium hydroxide, dibenzoylmethane and Bisphenol A (BPA).

VOLUME OF PRODUCT IN COMMERCE 302 bottles

DISTRIBUTION TN

WEEK ENDING MAY 5

Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

Dear Physician,

Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and eight prescriptions. The physicians have been contacted and all prescriptions accounted. As a precaution Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. All offices have been contacted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

PRODUCT Morphine Sulfate Injection, USP 4mg/mL, 1mL Carpuject, 10 Carpuject Sterile Cartridge Units with Luer Lock, NDC 0409-1258-30

CODE Lot 10830LL, Exp 4/1/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira, Inc., Lake Forest, IL 60045

Manufacturer: Hospiral Inc., Lake Forest, IL 60045

REASON FOR RECALL Superpotent; some cartridges labeled to contain 1mL may actually contain 2.2mL

PRODUCT MethylPREDNISolone Tablets, USP, 4 mg, 1 Unit For Dose Pack, 21 Tablets, Rx only, NDC 0603-4593-15.

CODE Lot Number: S003M11, Exp 9/13

RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL

REASON Labeling: Label-Mix Up: One unit dose package of Prednisolone, USP, 4 mg, was found with the back of the blister card which has the dosing instructions rotated 180 degrees such that there is one tablet in the row for Day 1 (versus 6 tablets) and six tablets in the row for Day 6 (versus 1 tablet).

VOLUME OF PRODUCT IN COMMERCE 109,143 cartons

DISTRIBUTION Nationwide

PRODUCT Little Fevers Children's Fever/Pain Reliever (acetaminophen) liquid, 160 mg/ 5 mL, Natural Cherry Flavor, 4 fl. oz. (118 mL) bottle; UPC Code: 7 56184 10124 7.

CODE Lot #: 574-1913, 574-1938, 574-1943, Exp 09/12; 574-1979, 574-1980, 574-2008, Exp 10/12; 574-2009, Exp 11/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Medtech Products, Inc., Irvington, NY,

Manufacturer: Guardian Drug Co. Inc.m Dayton, NJ.

REASON

Resuspension Problems: Little Fevers Children's Fever/Pain Reliever (acetaminophen) Liquid, 160 mg/ 5 mL, Dye-Free Natural Cherry Flavor because of crystallization identified as acetaminophen may come out of suspension in the products.

VOLUME OF PRODUCT IN COMMERCE 188,784 bottles

DISTRIBUTION Nationwide

PRODUCT

1) Tetracycline HCl Capsules USP, 250 mg, Rx only, packaged in a) 100-count capsules per carton (NDC 0172-2416-10), UPC 3 0172-2416-10 1, packaged in 10 cards of 10 x 1-count capsules per blister (NDC 0172-2416-00); b) 100-count bottles (NDC 0172-2416-60), UPC 3 0172-2416-60 6; and c) 1000-count bottles (NDC 0172-2416-80), UPC 3 0172-2416-80 4.

2) Tetracycline HCl Capsules USP, 500 mg, Rx only, packaged in a) 100-count capsules per carton (NDC 0172-2407-10), UPC 3 0172-2407-10 1, packaged in 10 cards of 10 x 1-count capsules per blister (NDC 0172-2407-00); b) 100-count bottles (NDC 0172-2407-60), UPC 3 0172-2407-60 4; and c) 1000-count bottles (NDC 0172-2407-80), UPC 3 0172-2407-80 2.

CODE

1) Lot #: a) 317297, Exp 08/12; 34000390A, Exp 11/12; 34002112A, Exp 03/13; b) 702101, Exp 04/12; 33401717A, Exp 05/12; 33402259A, Exp 08/12; 33402394B, Exp 10/12; 315037, 316165, Exp 05/13; 317237, 115032A, Exp 08/13; 34000391A, 34000392A, Exp 11/13; 34002112B, 34002113A, Exp 03/14; 34002114A, Exp 04/14; c) 33401718A, Exp 05/12; 33401719A, Exp 06/12; 33402144A, Exp 07/12; 33402258A, 33402259B, 702950, 702951, Exp 08/12; 33402392A, 33402393A, Exp 10/12; 316512, 316513, Exp 05/13; 317238, 317338, 115031B, Exp 08/13; 34000390B, Exp 11/13; 34002110A, 34002111A, Exp 02/14; 34002115C, Exp 04/14; 34000393A, Exp 11/14;

2) Lot #: a) 115767B, Exp 10/12; 34000663A, Exp 01/13; 34002104A, Exp 04/13; b) 33401714A, Exp 05/12; 33402143A, 702953, Exp 07/12; 33402422A, 33402423A, Exp 08/12; 33402426A, Exp 09/12; 33402427A, 33402451A, 33402545A, Exp 10/12; 702836, 702954, Exp 11/12; 33402664A, Exp 12/12; 315857, 315858, 315859, 315958, 315959, Exp 04/13; 315856, Exp 05/13; 316709, 316991, 316992, 316993, 317491, Exp 07/13; 317601, 317619, 317620, 317621, 317622, Exp 09/13; 115764A, 115765A, Exp 10/13; 34000662A, 115768A, 34000663B, 34000664A, 34000667A, Exp 01/14; 34002095A, 34002100B, 34002101A, Exp 03/14; 34002108B, Exp 05/14; c) 33401715A, Exp 05/12; 33401716A, Exp 06/12; 33402424A, 33402425A, Exp 09/12; 33402450A, Exp 10/12; 33402546A, 33402550A, Exp 11/12; 33402665A, Exp 12/12; 316225, 316785, Exp 04/13; 315863, 316093, 316094, 316511, Exp 05/13; 316994, 316995, 316996, Exp 07/13; 317236, 317813, 317814, 317815, Exp 09/13; 115766A, 115767A, Exp 10/13; 34000665A, 34000666A, Exp 01/14; 34002096A, 34002098A, 34002099A, 34002102A, Exp 03/14; 34002104C, 34002105B, 34002106B, Exp 04/14

RECALLING FIRM/MANUFACTURER

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

Manufacturer: Barr Laboratories, Inc. (div. Of Teva), Forest, VA.

REASON

Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.

VOLUME OF PRODUCT IN COMMERCE 1,006,117 cartons and bottles

DISTRIBUTION Nationwide and PR

PRODUCT

1) buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, packaged in a) 30-count tablets per bottle (NDC 67767-142-30), b) 90-count tablets per bottle (NDC 67767-142-90), c) 500-count tablets per bottle (NDC 67767-142-05), Rx only.

2) buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, packaged in a) 30-count tablets per bottle (NDC 67767-141-30), b) 90-count tablets per bottle (NDC 67767-141-90), Rx only.

CODE

1) Lot #: a) 759C11, 760C11, 761C11; Exp 01/12; CE0D06A, CE0D07A, CE0D08A, Exp 04/12; 482K01, CH0D20A, CH0D23A, CH0D25A, CH0D28A, CH0D31A, Exp 07/12; 244K01, 546K01, 547K01, 553K01, CJ0D05A, CJ0D12A, CJ0D13A, CJ0D14A, CJ0D15A, CJ0D18A, Exp 08/12; 332A11, Exp 12/12; b) CE0D09A, Exp 04/12; 481K01, Exp 07/12; 243K01, 545K01, CJ0D09A, CJ0D11A, Exp 08/12; 248M01, 330A11, Exp 11/12; 333A11, Exp 12/12; c) CE0D10A, CE0D11A, CE0D12A, Exp 04/12; CH0D16B, CH0D17B, CH0D18A, CH0D19A, CH0D21A, CH0D22A, CH0D24A, CH0D29A, CH0D30A, Exp 07/12; 245K01, Exp 08/12, CJ0D23A, CJ0D24A, Exp 09/12;

2) Lot #: a) 549K01, 584K01, 644L01, 645L01 646L01, 647L01 648L01, CK0D12A, CK0D13A, CK0D14A, CK0D15A, CK0D16A, CK0D17A, Exp 01/12; CL0D03A, CL0D04A, Exp 02/12; 303M01, Exp 03/12; 476B11, 477B11, 478B11, 479B11, 570B11, 571B11, Exp 04/12; CF0D01A, CF0D02A, CF0D05A, CF0D21A, CF0D22A, Exp 05/12; CG0D07A, CG0D08A, CG0D09A, CG0D12A, CG0D26A, Exp 06/12; CG1D10A, Exp 10/12; 550K01, 551K01, 552K01, Exp 11/12; b) 548K01, CK0D18A, CK0D19A, CK0D20A, Exp 01/12; CL0D01A, CL0D02A, Exp 02/12; 228A11, 229A11, 272M01, 273M01 304M02, CD0D15A, CM0D02A, Exp 03/12; 526B11, 553B11, Exp 04/12; CF0D06A, CF0D07A, CF0D08A, CF0D23A, CF0D24A, Exp 05/12; CG0D01A, CG0D02A, CG0D03A, CG0D04A, CG0D05A, CG0D06A, CG0D10A, CG0D11A, CG0D25A, CG0D27A, CG0D28A; 06/12; CH0D01A, CH0D02A, CH0D03A, CH0D05B, CH0D06B, CH0D07B, CH0D10B, Exp 07/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Actavis South Atlantic LLC, Sunrise, FL,

Manufacturer: CMIC CMO USA Corp., Cranbury, NJ.

REASON Failed USP Dissolution Test Requirements: Out of specification results for dissolution were obtained at the 8-hour stability testing point, all other time points at 2, 3, and 16-hours met specification.

VOLUME OF PRODUCT IN COMMERCE 1,994,272 bottles

DISTRIBUTION Nationwide and PR