Drugs Recalls

FDA Drug Class II Terminated

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

August 28, 2012 Hospira, Inc. 26,100 vials units

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

August 28, 2012 Hospira, Inc. 172,350 vials units

FDA Drug Class I Terminated

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

August 27, 2012 Samantha Lynn, Inc 25,888 Boxes units

FDA Drug Class III Terminated

Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30

August 23, 2012 Stat Rx USA 5 bottles units

FDA Drug Class I Terminated

Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351

August 23, 2012 Evol Nutrition 1000 blister packs (total both products) units

FDA Drug Class III Terminated

Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manuf

August 23, 2012 Ferring Pharmaceuticals Inc 146,867 Vials units

FDA Drug Class I Terminated

Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351

August 23, 2012 Evol Nutrition 1000 blister packs (total both products) units

FDA Drug Class II Terminated

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per

August 21, 2012 Caraco Pharmaceutical Laboratories Ltd. a) 2424 Cartons b) 2675 Cartons units

FDA Drug Class II Terminated

Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019

August 21, 2012 Ranbaxy Inc. 32,208 bottles units

FDA Drug Class III Terminated

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

August 17, 2012 Axcentria Pharmaceuticals LLC 17,679 bottles units

FDA Drug Class I Terminated

HYDROmorphone HCl Injection, USP, 2 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 0409

August 15, 2012 Hospira, Inc. 216,880 cartridge units units

FDA Drug Class III Terminated

Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceut

August 15, 2012 Galderma Laboratories, L.P. 17,160 bottles units

FDA Drug Class III Terminated

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured

August 14, 2012 Actavis Mid Atlantic LLC 19,980 Bottles units

FDA Drug Class III Terminated

Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Ro

August 14, 2012 Actavis Mid Atlantic LLC 14,868 Bottles units

FDA Drug Class III Terminated

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc.

August 14, 2012 Bracco Diagnostic Inc 196,280 Vials units

FDA Drug Class II Terminated

Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for

August 7, 2012 Mylan Pharmaceuticals Inc. 24,331 bottles units

FDA Drug Class II Terminated

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

August 3, 2012 Hospira, Inc. 56,420 vials units

FDA Drug Class II Terminated

Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30

August 1, 2012 Dr. Reddy's Laboratories, Inc. 27,805 bottles units

FDA Drug Class II Terminated

Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30

August 1, 2012 Dr. Reddy's Laboratories, Inc. 48, 754 bottles (C108376)/47,520 bottles (C108634) units

FDA Drug Class II Terminated

Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30

August 1, 2012 Dr. Reddy's Laboratories, Inc. 86, 093 bottles units

FDA Drug Class I Terminated

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Ge

July 30, 2012 Genentech Inc 2,140 kits units

FDA Drug Class III Terminated

Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1

July 30, 2012 Mallinckrodt Inc. 12/2.8mCi-vials and 12/6.3mCi-vials units

FDA Drug Class II Terminated

Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

July 27, 2012 Mylan Pharmaceuticals Inc. 960 bottles units

FDA Drug Class III Terminated

Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.

July 27, 2012 Natural Essentials Inc 11,058 bottles units

FDA Drug Class II Terminated

Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr.,

July 27, 2012 Capco Custom Packaging Inc 14380 Bottles units

FDA Drug Class II Terminated

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSm

July 26, 2012 GlaxoSmithKline Inc 1,412,566 inhalers units

FDA Drug Class II Terminated

Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 25, 2012 Lloyd Inc. of Iowa 3,789,426/50-mcg. tablets units

FDA Drug Class III Terminated

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, P

July 25, 2012 American Health Packaging 1,170 cartons units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lou

July 25, 2012 Lloyd Inc. of Iowa 37,441/100-tablet bottles units

FDA Drug Class II Terminated

Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA

July 25, 2012 Lloyd Inc. of Iowa 1,924,133/75-mcg. tablets 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

July 25, 2012 Lloyd Inc. of Iowa 16,548/100-tablet bottles units

FDA Drug Class II Terminated

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102

July 24, 2012 Cadence Pharmaceuticals 1,098,912 vials units

FDA Drug Class II Terminated

CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray als

July 23, 2012 Custom Medical Specialties, Inc. 20 Trays units

FDA Drug Class II Terminated

Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains o

July 23, 2012 Custom Medical Specialties, Inc. 35 Trays units

FDA Drug Class III Terminated

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-2

July 23, 2012 Stat Rx USA 51 Bottles units

FDA Drug Class II Terminated

Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511

July 23, 2012 American Health Packaging 694 cartons units

FDA Drug Class II Terminated

CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568,

July 23, 2012 Custom Medical Specialties, Inc. 25 Trays units

FDA Drug Class II Terminated

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.

July 19, 2012 Abbott Laboratories 53,448 Bottles units

FDA Drug Class II Terminated

Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.

July 19, 2012 Abbott Laboratories 42,596 Bottles units

FDA Drug Class II Terminated

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90

July 19, 2012 Abbott Laboratories 40,464 Bottles units

FDA Drug Class II Terminated

Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item

July 18, 2012 LNK International, Inc. 9,379 bottles units

FDA Drug Class III Terminated

Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15

July 18, 2012 Fougera Pharmaceuticals, Inc. 60,210 units units

FDA Drug Class I Terminated

X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manu

July 16, 2012 Coral Rock Man, Inc. unknown units

FDA Drug Class I Terminated

Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066

July 16, 2012 Coral Rock Man, Inc. unknown units

FDA Drug Class II Terminated

CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net W

July 13, 2012 Island Kinetics dba Covalence 5311 bottles units

FDA Drug Class III Terminated

Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,

July 12, 2012 Axcentria Pharmaceuticals LLC 13,128 bottles 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, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 177,900 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, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 121,530 patches 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, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 231,270 patches units

FDA Drug Class II Terminated

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (N

July 11, 2012 Actavis 98,088 cartons (5 pouches per carton) units