Drug product
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
D-0912-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,280 cartons
- Official record key
drug-enforcement:D-0912-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) 2FV1948, 2ER0285, 2ER0411, Exp. Date 01/24 b)2CR0653, Exp. Date 12/23 c)2GR0331, Exp. Date 04/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications