Drug product
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
D-0821-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 91788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0821-2023
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