US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1

Reason Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. NDC 0409-7670-09 D-0277-2015
Class II · Moderate risk Terminated

Assured Naproxen Sodium Tablets

Reason Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP

Contract Packaging Resources Inc. D-0248-2015
Class II · Moderate risk Terminated

Glimepiride Tablets

Reason Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

Micro Labs Usa, Inc S NDC 42571-101-01 D-0046-2015
Class II · Moderate risk Terminated

Dextroamphetamine Saccharate

Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.

Teva Pharmaceuticals USA D-0050-2015
Class II · Moderate risk Terminated

ZEE Aspirin 325mg - 24 tablets in single dose packets

Reason Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.

Zee Medical Products Inc D-0041-2015
Class II · Moderate risk Terminated

Vancomycin Hydrochloride for Injection

Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Hospira Inc. NDC 0409-6533-01 D-0390-2015
Class II · Moderate risk Terminated

Ketorolac Tromethamine Inj.

Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Hospira Inc. NDC 0409-3796-01 D-0388-2015
Class II · Moderate risk Terminated

Vancomycin Hydrochloride for Injection

Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Hospira Inc. NDC 0409-4332-01 D-0387-2015
Class II · Moderate risk Terminated

Vitamin B Complex

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0228-2015
Class II · Moderate risk Terminated

Vancomycin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0227-2015
Class II · Moderate risk Terminated

Triesence

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0226-2015
Class II · Moderate risk Terminated

Tobramycin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection

Oregon Compounding Centers, Inc. dba Creative Compounds D-0225-2015
Class II · Moderate risk Terminated

Testosterone Cypionate

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0224-2015
Class II · Moderate risk Terminated

Testosterone Cypionate

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0223-2015
Class II · Moderate risk Terminated

Sodium Chloride Inhalation

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0222-2015
Class II · Moderate risk Terminated

Pyridoxine HCL

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0221-2015
Class II · Moderate risk Terminated

Procaine HCL

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0220-2015
Class II · Moderate risk Terminated

PREDNISOLONE Sodium Phosphate

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0219-2015
Class II · Moderate risk Terminated

Papaverine/Phentolamine/Prostaglandin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0218-2015
Class II · Moderate risk Terminated

Papaverine/Phentolamine/Prostaglandin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0217-2015
Class II · Moderate risk Terminated

Papaverine/Phentolamine/Prostaglandin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..

Oregon Compounding Centers, Inc. dba Creative Compounds D-0216-2015
Class II · Moderate risk Terminated

Papaverine/Phentolamine/Alprostadil

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0215-2015
Class II · Moderate risk Terminated

Papaverine Hcl/Phentolamine/Prostaglandin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0214-2015
Class II · Moderate risk Terminated

Papaverine Hcl/Phentolamine Mes/Prostaglandin

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0213-2015
Class II · Moderate risk Terminated

Papaverine Hcl/Phentolamine Mes/Alprostadil

Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Oregon Compounding Centers, Inc. dba Creative Compounds D-0212-2015