Drug product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
D-0839-2020
Product summary
- Firm
- Akorn Inc
- Event
- Event 84913
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,078 bottles
- Official record key
drug-enforcement:D-0839-2020
Official wording
Reason: Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Code information: Lot #: 364667, Exp 12/20/2019
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent