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Recall Observatory FDA recall evidence

Drug product

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

D-0907-2023

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 91672
Status
Terminated
Classification
Class II
Quantity
15,504 cartons
Official record key
drug-enforcement:D-0907-2023

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: 2DR0351, Exp. date 12/23

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications