Drugs Recalls

FDA Drug Class III Terminated

Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.

April 5, 2012 Hospira, Inc. 164,568 containers units

FDA Drug Class II Terminated

Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dos

April 2, 2012 Teva Pharmaceuticals USA, Inc. 4188 cartons (5 X 5 blisterpacks) units

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739

March 29, 2012 McKesson Packaging Services 674 cartons units

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739

March 29, 2012 McKesson Packaging Services 187 cartons units

FDA Drug Class II Terminated

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, M

March 22, 2012 Noven Pharmaceuticals, Inc. 185,160 patches units

FDA Drug Class III Terminated

DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070

March 20, 2012 Quadrant Chemical Corporation 4800 bottles units

FDA Drug Class III Terminated

Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08

March 16, 2012 Ranbaxy Inc. 2544 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Penning

March 14, 2012 Zydus Pharmaceuticals USA Inc 1176 Bottles units

FDA Drug Class I Ongoing

Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

March 10, 2012 The Menz Club, LLC 50,000 capsules units

FDA Drug Class II Terminated

Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India

March 9, 2012 Aurobindo Pharma LTD 23,616 bottles units

FDA Drug Class III Terminated

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 03

March 9, 2012 Pack Pharmaceuticals 4,848 bottles units

FDA Drug Class II Terminated

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier,

March 8, 2012 Shionogi Inc. 7230 bottles units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lou

February 24, 2012 Lloyd Inc 19,039 bottles units

FDA Drug Class II Terminated

Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601.

February 24, 2012 Lloyd Inc 1,913,236 tablets units

FDA Drug Class I Terminated

Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan

February 23, 2012 www.vitaminbestbuy.com 69 boxes units

FDA Drug Class I Terminated

Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY

February 23, 2012 www.vitaminbestbuy.com 52 boxes units

FDA Drug Class I Terminated

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18,

February 23, 2012 www.vitaminbestbuy.com 550 boxes units

FDA Drug Class II Terminated

PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09

February 20, 2012 Physicians Total Care, Inc. 3660 capsules units

FDA Drug Class II Terminated

PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08

February 20, 2012 Physicians Total Care, Inc. 1200 capsules units

FDA Drug Class II Terminated

Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0

February 8, 2012 Physicians Total Care, Inc. 3 bottles units

FDA Drug Class II Terminated

Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10

February 6, 2012 sanofi-aventis US, Inc. 196,355 vials units

FDA Drug Class II Terminated

Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20

February 6, 2012 sanofi-aventis US, Inc. 387,738 vials units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St.

February 3, 2012 Lloyd Inc 19,166 bottles units

FDA Drug Class II Terminated

Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

February 3, 2012 Lloyd Inc 1,924,297 bulk tablets units

FDA Drug Class I Terminated

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

December 19, 2011 Body Basics Inc 30,000 capsules units

FDA Drug Class I Terminated

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD,

December 2, 2011 Eagle Pharmaceuticals Inc. 19,660 vials units

FDA Drug Class II Terminated

Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www

November 10, 2011 Victus, Inc. 1,535 Tubes units

FDA Drug Class II Terminated

ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA

November 8, 2011 Carefusion 213, Llc 67,775 Applicators units

FDA Drug Class II Terminated

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30

October 17, 2011 Meda Pharmaceuticals Inc. 478,569 Softgel Capsules (172,740 trade plus 305,829 samples). units

FDA Drug Class II Terminated

Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50

September 30, 2011 VistaPharm, Inc. 27,221 unit dose cups units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 1

September 27, 2011 Shamrock Medical Solutions Group LLC 99/500 mg tablets units

FDA Drug Class I Terminated

metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 537

September 27, 2011 Shamrock Medical Solutions Group LLC 88/5 mg tablets units

FDA Drug Class II Terminated

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical

September 27, 2011 Shamrock Medical Solutions Group LLC 284/800 mg tablets units

FDA Drug Class I Terminated

Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696

September 27, 2011 Shamrock Medical Solutions Group LLC 89/120 mg tablets units

FDA Drug Class II Terminated

Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia

September 27, 2011 Shamrock Medical Solutions Group LLC 99/240 mg softgel caps units

FDA Drug Class I Terminated

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody L

September 27, 2011 Shamrock Medical Solutions Group LLC 55/1 mL/20mg/mL syringe units

FDA Drug Class II Terminated

Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. se

September 19, 2011 Physicians Total Care, Inc. a) 4 bottles; b) 2 bottles units

FDA Drug Class II Terminated

Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15

July 6, 2011 Bausch & Lomb, Inc. 59,777 bottles units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Ma

July 5, 2011 Noven Pharmaceuticals, Inc. 244,320 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Ma

July 5, 2011 Noven Pharmaceuticals, Inc. 242,100 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Ma

July 5, 2011 Noven Pharmaceuticals, Inc. 335,190 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US

July 5, 2011 Noven Pharmaceuticals, Inc. 357,510 patches units

FDA Drug Class II Terminated

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporati

June 22, 2011 Nephron Pharmaceuticals Corp. 56,028 cartons units

FDA Drug Class III Terminated

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

June 15, 2011 Apotex Corp. 963,407 bottles units

FDA Drug Class II Terminated

ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090

May 27, 2011 A B Nutrition, Inc. 912 bottles units

FDA Drug Class II Terminated

PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090

May 27, 2011 A B Nutrition, Inc. 509 bottles units

FDA Drug Class II Terminated

PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090

May 27, 2011 A B Nutrition, Inc. 2980 bottles units

FDA Drug Class III Terminated

Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode

May 23, 2011 Physicians Total Care, Inc. 1 bottle units

FDA Drug Class III Terminated

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, I

April 8, 2011 Physicians Total Care, Inc. 5 Bottles units

FDA Drug Class III Terminated

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, I

April 8, 2011 Physicians Total Care, Inc. 5 bottles units