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FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated Mar 23, 2016

Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta…

Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.

TMIG Inc D-0855-2016

Class II · Moderate risk Terminated Mar 14, 2016

Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC…

Reason Failed Impurities/Degradation Specifications

Impax Laboratories, Inc. NDC 64720-215-10 D-0826-2016

Class II · Moderate risk Terminated Mar 14, 2016

Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC…

Reason Failed Impurities/Degradation Specifications

Impax Laboratories, Inc. NDC 64720-0216-10 D-0825-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200…

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0808-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV…

Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.

Meditech Laboratories, Inc D-0807-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech…

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0806-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech…

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0805-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech…

Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.

Meditech Laboratories, Inc D-0804-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc…

Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.

Meditech Laboratories, Inc D-0803-2016

Class II · Moderate risk Terminated Mar 14, 2016

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech…

Reason Superpotent Drug: one ingredient was found to be above assay specification.

Meditech Laboratories, Inc D-0802-2016

Class II · Moderate risk Terminated Mar 8, 2016

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. NDC 0409-7077-14 D-0832-2016

Class II · Moderate risk Terminated Mar 8, 2016

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. D-0831-2016

Class II · Moderate risk Terminated Mar 8, 2016

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. D-0830-2016

Class II · Moderate risk Terminated Mar 8, 2016

Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. NDC 0409-7935-19 D-0829-2016

Class II · Moderate risk Terminated Mar 8, 2016

Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. NDC 0409-7936-19 D-0828-2016

Class II · Moderate risk Terminated Mar 8, 2016

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…

Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Hospira Inc. NDC 0409-7918-19 D-0827-2016

Class II · Moderate risk Terminated Mar 3, 2016

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally…

Reason Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

Dr. Reddy's Laboratories, Inc. NDC 55111-688-52 D-0784-2016

Class II · Moderate risk Terminated Mar 1, 2016

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT…

Reason Cross contamination with other products: metronidazole

Sagent Pharmaceuticals Inc NDC 25021-0113-82 D-0780-2016

Class II · Moderate risk Terminated Feb 16, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct…

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

Actavis Elizabeth LLC D-0816-2016

Class II · Moderate risk Terminated Feb 16, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct…

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

Actavis Elizabeth LLC D-0815-2016

Class II · Moderate risk Terminated Feb 16, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct…

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

Actavis Elizabeth LLC D-0814-2016

Class II · Moderate risk Terminated Feb 16, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct…

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

Actavis Elizabeth LLC D-0813-2016

Class II · Moderate risk Terminated Feb 16, 2016

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials…

Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.

Genzyme Corporation NDC 58468-0030-2 D-0730-2016

Class II · Moderate risk Terminated Feb 16, 2016

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials…

Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.

Genzyme Corporation NDC 58468-1849-04 D-0729-2016

Class II · Moderate risk Terminated Feb 12, 2016

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC…

Reason Failed Dissolution Specifications; three month stability time point.

Mylan Pharmaceuticals Inc. NDC 0378-3978-93 D-0840-2016