Drug product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
D-1875-2019
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 83700
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5953 bottles
- Official record key
drug-enforcement:D-1875-2019
Official wording
Reason: Failed Stability Specifications.
Code information: Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications