Drug product
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.
D-0900-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,904 cartons
- Official record key
drug-enforcement:D-0900-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot # a) 2GR0329, Exp. date 04/24 Lot # b) 2DR0472, Exp. date 02/23; 2MR0417, Exp. date 07/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications