Drugs Recalls

FDA Drug Class II Terminated

Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville,

May 16, 2012 Teva Pharmaceuticals USA, Inc. 2,268 bottles units

FDA Drug Class II Terminated

Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05

May 14, 2012 Abbott Laboratories 121,000 vials units

FDA Drug Class I Terminated

HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 040

May 12, 2012 Hospira, Inc. 223,750 prefilled cartridge units units

FDA Drug Class II Terminated

Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

May 9, 2012 Grandpa Brands Co Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package) units

FDA Drug Class III Terminated

Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morto

May 8, 2012 Morton Salt Co. 531,950 lbs units

FDA Drug Class III Terminated

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 281

May 8, 2012 Hill Dermaceuticals, Inc. 111,816 bottles units

FDA Drug Class III Terminated

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFOR

May 8, 2012 Hill Dermaceuticals, Inc. 161,064 bottles units

FDA Drug Class II Terminated

Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.

May 8, 2012 Bayer HealthCare Pharmaceuticals Inc. 112.295 kg units

FDA Drug Class III Terminated

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

May 7, 2012 Guthy-Renker LLC 5,025 Compacts units

FDA Drug Class III Terminated

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

May 7, 2012 Guthy-Renker LLC 4,526 Compacts units

FDA Drug Class III Terminated

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

May 7, 2012 Guthy-Renker LLC 9,960 Compacts units

FDA Drug Class III Terminated

Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501;

May 7, 2012 Endo Pharmaceuticals, Inc. 11,764 bottles units

FDA Drug Class III Terminated

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

May 7, 2012 Guthy-Renker LLC 29,341 Compacts units

FDA Drug Class III Terminated

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

May 7, 2012 Guthy-Renker LLC 2,537 Compacts units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

May 4, 2012 Hospira, Inc. 2,933,936 units units

FDA Drug Class II Terminated

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48

May 4, 2012 Hospira, Inc. 74,256 units units

FDA Drug Class II Terminated

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

May 4, 2012 Hospira, Inc. 98,084 units units

FDA Drug Class II Terminated

1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08

May 4, 2012 Hospira, Inc. 40,988 units units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by

May 4, 2012 Hospira, Inc. 2,137,660 units units

FDA Drug Class II Terminated

0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02

May 4, 2012 Hospira, Inc. 136,584 units units

FDA Drug Class II Terminated

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

May 4, 2012 Hospira, Inc. 267,288 units units

FDA Drug Class II Terminated

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hosp

May 4, 2012 Hospira, Inc. 216,396 units units

FDA Drug Class II Terminated

LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde

May 4, 2012 Linde Gas LLC 283 cylinders units

FDA Drug Class II Terminated

70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07

May 4, 2012 Hospira, Inc. 14,706 units units

FDA Drug Class II Terminated

Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceutical

May 2, 2012 Teva Pharmaceuticals USA, Inc. 100,761 cartons units

FDA Drug Class II Terminated

Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for:

May 1, 2012 Ben Venue Laboratories Inc 11,161 packs units

FDA Drug Class II Terminated

Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Man

May 1, 2012 Ben Venue Laboratories Inc 6,515 packs units

FDA Drug Class II Terminated

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, C

April 30, 2012 Apotex Inc. 119,794 Bottles units

FDA Drug Class III Terminated

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005

April 26, 2012 Bayer Healthcare, LLC 48,528 cartons units

FDA Drug Class III Terminated

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24

April 26, 2012 Bayer Healthcare, LLC 119,412 cartons units

FDA Drug Class II Terminated

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25

April 24, 2012 Luitpold Pharmaceuticals, Inc. 63,750 ampules units

FDA Drug Class III Terminated

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

April 24, 2012 Teva Pharmaceuticals USA, Inc. 13,232 bottles units

FDA Drug Class III Terminated

Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc.,

April 23, 2012 Teva Pharmaceuticals USA, Inc. 40,750 Dispensers units

FDA Drug Class II Terminated

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator

April 23, 2012 Carefusion 213, Llc 576 Cartons units

FDA Drug Class I Terminated

X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on l

April 21, 2012 XRock Industries, LLC 215,000 capsules units

FDA Drug Class III Terminated

Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01

April 17, 2012 Watson Laboratories Inc 18,902 bottles units

FDA Drug Class III Terminated

Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

April 17, 2012 Watson Laboratories Inc 106,323 bottles units

FDA Drug Class III Terminated

Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01

April 17, 2012 Watson Laboratories Inc 21,572 bottles units

FDA Drug Class III Terminated

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

April 17, 2012 Watson Laboratories Inc 8254 bottles units

FDA Drug Class I Terminated

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-3

April 17, 2012 Hospira, Inc. 212,370 cartidges units

FDA Drug Class III Terminated

Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01

April 17, 2012 Watson Laboratories Inc 7,262 bottles units

FDA Drug Class III Terminated

Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15

April 16, 2012 Bracco Diagnostics Inc 47,750 vials units

FDA Drug Class II Terminated

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Via

April 16, 2012 Bracco Diagnostics Inc 4,870 Vials units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portuga

April 13, 2012 West-ward Pharmaceutical Corp. a) 308,275 vials; b) 2,008,850 vials units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Port

April 13, 2012 West-ward Pharmaceutical Corp. a) 74,960 vials; b) 911,070 vials units

FDA Drug Class II Terminated

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

April 11, 2012 Hospira, Inc. a) 36,125 vials; b) 31,280 vials units

FDA Drug Class II Terminated

Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx

April 10, 2012 Airgas Inc 123 cylinders units

FDA Drug Class II Terminated

Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05

April 9, 2012 Dr. Reddy's Laboratories, Inc. 1656 bottles units

FDA Drug Class II Terminated

Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05

April 9, 2012 Dr. Reddy's Laboratories, Inc. 1656 bottles units

FDA Drug Class II Terminated

Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.

April 5, 2012 Apotex Corp. 1,749 Bottles units