Class II Recall

Akorn, Inc.

Product
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. 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