Class II Recall

Akorn, Inc.

Product
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Classification
Class II
Status
Ongoing
Lot
All Lots
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Akorn, Inc. — Class II Recall | MedicineWatch US