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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 13501–13520 of 17,832 recalls

Class IITerminated

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

May 22, 2015 · DrugView details →
Class IITerminated

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

May 22, 2015 · DrugView details →
Class IIITerminated

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

Novartis Pharmaceuticals Corp.

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

May 22, 2015 · DrugView details →
Class IITerminated

Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02

Blenheim Pharmacal, Inc.

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

May 22, 2015 · DrugView details →
Class IITerminated

SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433

Medtech Products, Inc.

Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

May 21, 2015 · DrugView details →
Class IITerminated

CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.

Takeda Pharmaceuticals North America, Inc.

Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.

May 21, 2015 · DrugView details →
Class IITerminated

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

Mylan Lab Inc

Failed Dissolution Specifications: Low out of specification dissolution results.

May 20, 2015 · DrugView details →
Class IIITerminated

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

Hospira Inc.

Failed pH Specifications: 12 month stability testing

May 19, 2015 · DrugView details →
Class IITerminated

HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · FDAView details →
Class IITerminated

ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · FDAView details →
Class IITerminated

NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
Class IITerminated

SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

May 18, 2015 · DrugView details →
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