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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Fresenius Kabi USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Apr 7, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.

Actavis Elizabeth

Class I - Dangerous

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

Feb 16, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.

Actavis Elizabeth

Class I - Dangerous

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

Feb 16, 2016 Prescription Drugs Nationwide View Details →

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.

Actavis Elizabeth

Class I - Dangerous

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

Feb 16, 2016 Prescription Drugs Nationwide View Details →

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 Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305

Virtus Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Product may contain leaking capsules.

Dec 17, 2015 Prescription Drugs Nationwide View Details →

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.

Actavis Elizabeth

Class I - Dangerous

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

Feb 16, 2016 Prescription Drugs Nationwide View Details →

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

Bio-pharm

Class I - Dangerous

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Dec 17, 2015 Prescription Drugs Nationwide View Details →

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Jubilant Draximage

Class I - Dangerous

Labeling: Label Error on Declared Strength

Mar 11, 2016 Prescription Drugs Nationwide View Details →

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

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 Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.

Apace KY

Class I - Dangerous

Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.

Feb 12, 2016 Prescription Drugs Nationwide View Details →

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.

Purdue Pharma L.P.

Class I - Dangerous

Failed Dissolution Specifications

Mar 31, 2016 Prescription Drugs View Details →

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Prescription Drugs Nationwide View Details →

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

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

Mar 14, 2016 Other Drugs Nationwide View Details →

Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

Walter's Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility

Feb 12, 2016 Prescription Drugs View Details →

Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

Walter's Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility

Feb 12, 2016 Prescription Drugs View Details →

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 - 500 043 INDIA NDC 55111-688-52

Dr. Reddy's Laboratories

Class I - Dangerous

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

Mar 3, 2016 Prescription Drugs Nationwide View Details →