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Recall Observatory FDA recall evidence

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

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications