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Recall Observatory FDA recall evidence

Drug product

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.

D-1874-2019

August 23, 2019

Class II

Product summary

Firm
Aurolife Pharma, LLC
Event
Event 83581
Status
Terminated
Classification
Class II
Quantity
4536 cartons
Official record key
drug-enforcement:D-1874-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: 067180024B1, 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