Drug product
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
D-0811-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 91788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0811-2023
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