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Recall Observatory FDA recall evidence

Drug product

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

D-1867-2019

August 23, 2019

Class II

Product summary

Firm
Aurolife Pharma, LLC
Event
Event 83581
Status
Terminated
Classification
Class II
Quantity
71,748 bottles
Official record key
drug-enforcement:D-1867-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications