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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 12101–12120 of 17,816 recalls

Class ITerminated

Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class ITerminated

Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

Marketed Without An Approved NDA/ANDA

January 9, 2016 · DrugView details →

Class IITerminated

Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895.

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

January 8, 2016 · DrugView details →

Class IITerminated

Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

January 8, 2016 · DrugView details →

Class IITerminated

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

Mayne Pharma Usa

Lack of Assurance of Sterility: Failed preservative effectiveness test

January 5, 2016 · DrugView details →

Class ITerminated

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

Hospira Inc.

Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

January 5, 2016 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Pharmedium Services, LLC

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

December 31, 2015 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

Pharmedium Services, LLC

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

December 31, 2015 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Sandoz Inc

Failed Impurities/Degradation Specifications; 9 month stability timepoint

December 31, 2015 · DrugView details →

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Complete Pharmacy and Medical Solutions LLC

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

December 29, 2015 · DrugView details →

Class IITerminated

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

TexasStar Pharmacy

Lack of assurance of sterility

December 29, 2015 · DrugView details →

Class IITerminated

IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

Amerita Specialty Infusion Services

Lack of Assurance of Sterility

December 24, 2015 · DrugView details →

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