Drug product
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
D-0908-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,376 cartons
- Official record key
drug-enforcement:D-0908-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24. Lot #: b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications