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Recall Observatory FDA recall evidence

Drug product

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.

D-1873-2019

August 23, 2019

Class II

Product summary

Firm
Aurolife Pharma, LLC
Event
Event 83581
Status
Terminated
Classification
Class II
Quantity
4920 cartons
Official record key
drug-enforcement:D-1873-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: 06718027A1, Exp 09/21

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications