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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

Amerisource Health Services

Class I - Dangerous

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

Aug 4, 2016 Prescription Drugs Nationwide View Details →

DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

Hospira

Class I - Dangerous

Discoloration: Firm received complaints of product discoloration and particulates.

Aug 15, 2016 Prescription Drugs Nationwide View Details →

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).

Teva North America

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.

Allergy Laboratories

Class I - Dangerous

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

Aug 10, 2016 Prescription Drugs Nationwide View Details →

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Teva North America

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06

Stason Pharmaceuticals

Class I - Dangerous

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

Aug 23, 2016 Prescription Drugs View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.

Teva North America

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)

Teva North America

Class I - Dangerous

CGMP Deviations

Jun 17, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06

Zydus Pharmaceuticals USA

Class I - Dangerous

Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.

May 9, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95

Amerisource Health Services

Class I - Dangerous

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09

Lupin Limited

Class I - Dangerous

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Feb 19, 2016 Prescription Drugs View Details →

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,

Isomeric Pharmacy Solution

Class I - Dangerous

Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.

Jun 29, 2016 Prescription Drugs Nationwide View Details →