Drug product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
D-1870-2019
Product summary
- Event
- Event 83581
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 10,992 cartons; b) 24,792 cartons
- Official record key
drug-enforcement:D-1870-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #s: a) 067180010B, Exp 03/21; 067180024E1, Exp 07/21; b) 067180016A, Exp 05/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications