US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated

Clindamycin Phosphate USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8198-3 D-0479-2018
Class II · Moderate risk Terminated

Celecoxib USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8635-4 D-0478-2018
Class II · Moderate risk Terminated

Calcipotriene BP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8630-1 D-0477-2018
Class II · Moderate risk Terminated

Baclofen USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8004-4 D-0476-2018
Class II · Moderate risk Terminated

Anastrozole USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8080-1 D-0475-2018
Class II · Moderate risk Terminated

Amitriptyline HCl USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8003-4 D-0474-2018
Class I · High risk Terminated

Hydromorphone

Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Pfizer Inc. D-0597-2018
Class I · High risk Terminated

Hydromorphone

Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Pfizer Inc. D-0596-2018
Class III · Low risk Terminated

BonaDur For Men

Reason CGMP Deviations: not manufactured according to current good manufacturing practices.

Webrx dba RxPalace.com NDC 70582-999-74 D-0421-2018
Class III · Low risk Terminated

Fluoxetine Tablets USP

Reason Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.

Teva Pharmaceuticals USA NDC 0093-7188-56 D-0578-2018
Class II · Moderate risk Terminated

100 mcg / mL Phenylephrine HCl

Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

PharMEDium Services, LLC D-0424-2018
Class II · Moderate risk Terminated

0.2% Ropivacaine HCI

Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

PharMEDium Services, LLC D-0423-2018
Class II · Moderate risk Terminated

15 units Oxytocin added to 0.9% Sodium Chloride Injection

Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

PharMEDium Services, LLC D-0422-2018
Class III · Low risk Terminated

Azelastine HCl Nasal Solution

Reason Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

Sun Pharmaceutical Industries, Inc. NDC 47335-779-91 D-0417-2018
Class III · Low risk Terminated

Klonopin

Reason Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Genentech, Inc. NDC 0004-0068-01 D-0416-2018
Class III · Low risk Terminated

Metformin Hydrochloride Tablets

Reason Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Aurobindo Pharma Ltd. NDC 65862-010-05 D-0427-2018
Class III · Low risk Terminated

Norco

Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

Allergan NDC 0023-6022-01 D-0413-2018
Class II · Moderate risk Terminated

Velcade

Reason Defective Container: Confirmed reports of loose vial crimps.

Millennium Pharmaceuticals Inc. NDC 63020-0049-01 D-0425-2018
Class III · Low risk Terminated

Fentanyl Transdermal System

Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Teva Pharmaceuticals USA NDC 0591-3214-72 D-0543-2018
Class III · Low risk Terminated

Fentanyl Transdermal System. 75 mcg/h

Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Teva Pharmaceuticals USA NDC 0591-3213-72 D-0542-2018
Class III · Low risk Terminated

Fentanyl Transdermal System

Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Teva Pharmaceuticals USA NDC 0591-3212-72 D-0541-2018
Class III · Low risk Terminated

Fentanyl Transdermal System. 25 mcg/h

Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Teva Pharmaceuticals USA NDC 0591-3198-72 D-0540-2018
Class III · Low risk Terminated

Atorvastatin Calcium Tablets 40 mg

Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Dr. Reddy's Laboratories, Inc. NDC 55111-123-05 D-0420-2018
Class III · Low risk Terminated

Atorvastatin Calcium Tablets 20 mg

Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Dr. Reddy's Laboratories, Inc. NDC 55111-122-05 D-0419-2018
Class III · Low risk Terminated

Atorvastatin Calcium Tablets 10 mg

Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Dr. Reddy's Laboratories, Inc. NDC 55111-121-05 D-0418-2018