US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

DEXPANTHENOL with preservative

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-0186-2015
Class II · Moderate risk Terminated

Dexamethasone

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-0185-2015
Class II · Moderate risk Terminated

Copper

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-0184-2015
Class II · Moderate risk Terminated

Citric Acid/Gluconolactone Magnes Carb

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-0183-2015
Class II · Moderate risk Terminated

Chorionic Gonadotropin

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-0182-2015
Class II · Moderate risk Terminated

Chorionic Gonadotropin

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-0181-2015
Class II · Moderate risk Terminated

Ceftazidime

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-0180-2015
Class II · Moderate risk Terminated

Calcium Chloride

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-0179-2015
Class II · Moderate risk Terminated

Bevacizumab/Dexamethasone

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-0178-2015
Class II · Moderate risk Terminated

Avastin

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-0177-2015
Class II · Moderate risk Terminated

Ascorbic Acid

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-0176-2015
Class II · Moderate risk Terminated

Ascorbic Acid

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-0175-2015
Class II · Moderate risk Terminated

Alprostadil/Lidocaine 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-0174-2015
Class II · Moderate risk Terminated

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-0173-2015
Class II · Moderate risk Terminated

CVS pharmacy

Reason Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.

Wisconsin Pharmacal Company NDC 68093-6150-1 D-0047-2015
Class II · Moderate risk Terminated

Ketorolac Tromethamine INJECTION

Reason Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

Sagent Pharmaceuticals Inc NDC 25021-701-01 D-0027-2015
Class II · Moderate risk Terminated

Emtriva

Reason Defective Container; leaking around the cap

Gilead Sciences, Inc. NDC 61958-0602-1 D-0045-2015
Class II · Moderate risk Terminated

Hydromorphone Hydrochloride Injection

Reason Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.

Hospira Inc. NDC 0703-0110-01 D-0044-2015
Class II · Moderate risk Terminated

Hydroxyprogesterone Caproate 250 Mg/Ml

Reason Crystallization: Formation of crystals observed in product.

Avella of Deer Valley, Inc. D-0016-2014
Class II · Moderate risk Terminated

DOPamine Hydrochloride and 5% Dextrose INJ

Reason Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Baxter Healthcare Corp. NDC 0338-1005-02 D-0004-2015
Class II · Moderate risk Terminated

Bystolic

Reason Failed Dissolution Specification; at the 6-month stability time point

Forest Pharmaceuticals Inc NDC 0456-1420-07 D-0036-2015
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP

Reason Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

Micro Labs Usa, Inc S NDC 42571-110-10 D-0253-2015