Drug product
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
D-0905-2023
Product summary
- Event
- Event 91672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360,184
- Official record key
drug-enforcement:D-0905-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 2DV1487, 2DV1870, 2DV1871, 2DV1873, 2EV1676, 2GV2132, 2HV2679, Exp. date 12/23; 2DV2000, exp. date 11/23; 2LV1573, 2MV1314, Exp. date 04/24; 2FV1764, 2FV1765 2FV1766, 2GV1579, 2GV1937, 2GV1941 , 2GV1942, 2GV2157, 2HV1886, 2HV1997, 2HV2019, 2HV2047, Exp. datev02/24; 2EV1666, 2EV1667, 2EV1668, 2EV1670, 2EV1671, 2EV1672, 2EV1674, 2EV1677, 2EV1678, 2HV2017, Exp. date 01/24.
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications