Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class I · High risk
Class I · High risk
Clopidogrel Tablets
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Class II · Moderate risk
Lovastatin Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Class I · High risk
Ampicillin and Sulbactam for Injection 1.5 g vial
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.