Drug product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
D-1868-2019
Product summary
- Event
- Event 83581
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 11,928 cartons; b) 288 cartons
- Official record key
drug-enforcement:D-1868-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #s: a) 067180016B, Exp 05/21 and b) 067180024F1, Exp 07/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications