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Prescription Drugs

💊 Drugs • 12,141 recalls

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

Sandoz

Class I - Dangerous

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Aug 24, 2016 Prescription Drugs Nationwide View Details →

Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jun 27, 2016 Prescription Drugs Nationwide View Details →

Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

W & C

Class I - Dangerous

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

Jun 20, 2016 Prescription Drugs View Details →

Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01

Genzyme Corporation / Genzyme Biosurgery

Class I - Dangerous

Labeling: Incorrect or Missing Lot and/or Exp. Date

Aug 4, 2016 Prescription Drugs Nationwide View Details →

Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jun 27, 2016 Prescription Drugs Nationwide View Details →

Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

W & C

Class I - Dangerous

Jun 20, 2016 Prescription Drugs View Details →

Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90

Aurobindo Pharma USA

Class I - Dangerous

Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

Aug 3, 2016 Prescription Drugs View Details →

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 →

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