FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Sep 23, 2013

Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by…

Reason Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in…

West-Ward Pharmaceutical Corp. NDC 0143-9701-01 D-66447-002

Class II · Moderate risk Terminated Sep 23, 2013

Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by…

Reason Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in…

West-Ward Pharmaceutical Corp. NDC 0143-9702-01 D-66447-001

Class II · Moderate risk Terminated Sep 23, 2013

Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54)…

Reason Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Watson Laboratories Inc NDC 52544-287-54 D-66360-001

Class II · Moderate risk Terminated Sep 17, 2013

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen…

Reason Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Amgen, Inc. NDC 55513-710-01 D-66318-001

Class II · Moderate risk Terminated Sep 17, 2013

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202…

Reason Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month…

Lupin Pharmaceuticals Inc. NDC 68180-557-09 D-409-2014

Class II · Moderate risk Terminated Sep 17, 2013

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United…

Reason Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month…

Lupin Pharmaceuticals Inc. NDC 68180-556-09 D-408-2014

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b)…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-452-20 D-1468-2016

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b)…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-451-20 D-1467-2016

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-450-20 D-1466-2016

Class II · Moderate risk Terminated Sep 16, 2013

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only…

Reason Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

Hospira, Inc. NDC 0409-1135-02 D-023-2014

Class II · Moderate risk Terminated Sep 16, 2013

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals…

Reason Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Kremers Urban Pharmaceuticals, Inc. D-009-2014

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5210-77 D-66403-012

Class II · Moderate risk Terminated Sep 13, 2013

Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-7098-01 D-66403-011

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6900-01 D-66403-010

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC#…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6898-01 D-66403-009

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6899-01 D-66403-008

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6897-01 D-66403-007

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6896-01 D-66403-006

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5209-77 D-66403-005

Class II · Moderate risk Terminated Sep 13, 2013

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-7097-01 D-66403-004

Class II · Moderate risk Terminated Sep 13, 2013

Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05)…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-4254-91 D-66403-003

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6895-01 D-66403-002

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5208-77 D-66403-001

Class II · Moderate risk Terminated Sep 13, 2013

Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories…

Reason Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen…

Watson Laboratories Inc NDC 0591-0825-01 D-66251-001

Class II · Moderate risk Terminated Sep 13, 2013

Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius…

Reason Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

AmeriSource Bergen NDC 0069-4496-22 D-1066-2013