Drugs Recalls

FDA Drug Class III Terminated

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,

March 12, 2013 L. Perrigo Co. 21,667 bottles units

FDA Drug Class III Terminated

Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per

March 12, 2013 Teva Pharmaceuticals USA, Inc. 17,661 blister cards units

FDA Drug Class III Terminated

Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratori

March 12, 2013 Teva Pharmaceuticals USA, Inc. 71,893 dispensers units

FDA Drug Class II Terminated

BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826

March 11, 2013 Palmer Natural Products 723 bottles units

FDA Drug Class II Terminated

Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .

March 11, 2013 Palmer Natural Products 4103 bottles units

FDA Drug Class II Terminated

Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL

March 11, 2013 Palmer Natural Products 250 bottles units

FDA Drug Class I Terminated

Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

March 11, 2013 Green Planet Inc 429,619 capsules units

FDA Drug Class II Terminated

Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826

March 11, 2013 Palmer Natural Products 472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles units

FDA Drug Class II Terminated

Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

March 11, 2013 Clinical Specialties Compounding Pharmacy 2190 syringes units

FDA Drug Class II Terminated

Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,

March 11, 2013 Palmer Natural Products 511 30 count bottles, 4103 100 count bottles units

FDA Drug Class III Terminated

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

March 11, 2013 Hi-Tech Pharmacal Co., Inc. 11,472 bottles units

FDA Drug Class II Terminated

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA

March 11, 2013 Gsms 6158 bottles units

FDA Drug Class II Terminated

Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826

March 11, 2013 Palmer Natural Products 557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles units

FDA Drug Class II Terminated

NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Buildi

March 11, 2013 Palmer Natural Products 672 bottles units

FDA Drug Class III Terminated

Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany,

March 7, 2013 Novartis Consumer Health 91,872/1-oz. tubes and 94,464/2-oz. tubes units

FDA Drug Class III Terminated

4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

March 7, 2013 Novartis Consumer Health 227,124 bottles units

FDA Drug Class III Terminated

4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles

March 7, 2013 Novartis Consumer Health 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles units

FDA Drug Class III Terminated

Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.

March 7, 2013 Novartis Consumer Health 240,120/2-oz. tubes and 429,144/4-oz. tubes units

FDA Drug Class III Terminated

4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis

March 7, 2013 Novartis Consumer Health 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles units

FDA Drug Class II Terminated

Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30

March 7, 2013 Sanofi US 2,462 bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington,

March 5, 2013 Zydus Pharmaceuticals USA Inc 13,320 bottles units

FDA Drug Class II Terminated

FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365

March 4, 2013 Carefusion 213, Llc 544,500 kits units

FDA Drug Class II Terminated

Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99,

March 4, 2013 Carefusion 213, Llc 46,500 kits units

FDA Drug Class II Terminated

SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.

March 4, 2013 Carefusion 213, Llc 698,000 applicators units

FDA Drug Class II Terminated

Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 543

March 4, 2013 Carefusion 213, Llc 929,000 kits units

FDA Drug Class II Terminated

SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. N

March 4, 2013 Carefusion 213, Llc 8,960,000 applicators units

FDA Drug Class II Terminated

SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, ND

March 4, 2013 Carefusion 213, Llc 3,032,000 applicators units

FDA Drug Class III Terminated

Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00

March 2, 2013 Physicians Total Care, Inc. 76 Tubes units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

February 27, 2013 Baxter Healthcare Corp. 317,280 bags units

FDA Drug Class III Terminated

FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA

February 27, 2013 Mutual Pharmaceutical Company, Inc.

FDA Drug Class III Terminated

Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA

February 27, 2013 Mutual Pharmaceutical Company, Inc.

FDA Drug Class III Terminated

Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07

February 27, 2013 Mutual Pharmaceutical Company, Inc.

FDA Drug Class II Terminated

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

February 26, 2013 Hospira, Inc. 114,000 vials units

FDA Drug Class III Terminated

Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10

February 26, 2013 Mylan Pharmaceuticals Inc. 2,405 bottles units

FDA Drug Class II Terminated

QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02

February 26, 2013 Hospira, Inc. 139,200 vials units

FDA Drug Class II Terminated

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04

February 26, 2013 Hospira, Inc. 259,050 vials units

FDA Drug Class II Terminated

Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

February 26, 2013 Sanofi-Synthelabo 998 Bottles units

FDA Drug Class II Terminated

Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73

February 26, 2013 Hospira, Inc. 266,900 vials units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.

February 26, 2013 Teva Pharmaceuticals USA, Inc. 62,187 bottles units

FDA Drug Class II Terminated

Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton,

February 25, 2013 Hospira, Inc. 68,020 vials units

FDA Drug Class III Terminated

Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai

February 22, 2013 Lupin Pharmaceuticals Inc. 4896 bottles units

FDA Drug Class II Terminated

Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

February 22, 2013 Petnet Solution Inc 28 doses units

FDA Drug Class III Terminated

Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 3006763823

February 19, 2013 Novartis Consumer Health 99,660 tubes units

FDA Drug Class III Terminated

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g

February 19, 2013 Novartis Consumer Health a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes units

FDA Drug Class III Terminated

Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (C

February 19, 2013 Novartis Consumer Health 41,400 Boxes units

FDA Drug Class III Terminated

Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067

February 19, 2013 Novartis Consumer Health 818,064 (12-gm) tubes and 836,376 (30-gm) tubes units

FDA Drug Class III Terminated

Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Ve

February 19, 2013 Novartis Consumer Health 219,600 tubes units

FDA Drug Class III Terminated

PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR

February 18, 2013 L. Perrigo Co. 60,048 Blister packs units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045

February 18, 2013 Hospira, Inc. 624,240 units units

FDA Drug Class III Terminated

Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distrib

February 15, 2013 Warner Chilcott Company LLC 17,136 bottles units