Class II · Moderate risk
Prolia (denosumab)
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Quinapril Tablets USP
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Class II · Moderate risk
Quinapril Tablets USP
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Class III · Low risk
Venlafaxine
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Ciprofloxacin Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Ciprofloxacin Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Lamotrigine Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
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 Tablets, USP 10/650 mg lot# 705791A.
Class II · Moderate risk
Ifosfamide Injection 3g/60 mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class II · Moderate risk
Ifosfamide Injection 1g/20mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.