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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Apr 18, 2017 Prescription Drugs Nationwide View Details →

PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Apr 18, 2017 Prescription Drugs Nationwide View Details →

VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Apr 18, 2017 Prescription Drugs Nationwide View Details →

SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Apr 18, 2017 Prescription Drugs Nationwide View Details →

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

Teva Pharmaceuticals USA

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Apr 24, 2017 Prescription Drugs Nationwide View Details →

Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Mar 22, 2017 Prescription Drugs Nationwide View Details →

Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Mar 22, 2017 Prescription Drugs Nationwide View Details →

Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.

PAR Sterile Products

Class I - Dangerous

Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.

Apr 28, 2017 Prescription Drugs Nationwide View Details →

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

Sanofi-Aventis U.S.

Class I - Dangerous

Labeling: Incorrect or Missing Package Insert

Sep 1, 2016 Prescription Drugs View Details →

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Stability Specifications

Mar 28, 2017 Prescription Drugs Nationwide View Details →

Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Mar 22, 2017 Prescription Drugs Nationwide View Details →

Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Mar 22, 2017 Prescription Drugs Nationwide View Details →

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

Akorn

Class I - Dangerous

Product is being recalled due to low pH value.

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

Amneal Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications

Dec 12, 2016 Prescription Drugs Nationwide View Details →

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

The Harvard Drug Group

Class I - Dangerous

Superpotent Drug; out of specification results for assay (manufacturer)

Dec 27, 2016 Prescription Drugs Nationwide View Details →

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

Fagron

Class I - Dangerous

Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Apr 17, 2017 Prescription Drugs Nationwide View Details →