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Recall Observatory FDA recall evidence

Drug product

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

D-1869-2019

August 23, 2019

Class II

Product summary

Firm
Aurolife Pharma, LLC
Event
Event 83581
Status
Terminated
Classification
Class II
Quantity
129,600 cartons
Official record key
drug-enforcement:D-1869-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #s: 067180010A, Exp 03/21; 067180023C1, 067180024D1, Exp 07/21

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications