Drug product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
D-0810-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 91788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0810-2023
Official wording
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Code information: All Lots
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations