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Recall Observatory FDA recall evidence

Drug product

Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.

D-1866-2019

August 23, 2019

Class II

Product summary

Firm
Aurolife Pharma, LLC
Event
Event 83581
Status
Terminated
Classification
Class II
Quantity
3240 cartons
Official record key
drug-enforcement:D-1866-2019

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: 067180024A1, 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