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Recall Observatory FDA recall evidence

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

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications