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Recall Observatory FDA recall evidence

Drug product

Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47

D-0901-2023

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 91672
Status
Terminated
Classification
Class II
Quantity
23,868 cartons
Official record key
drug-enforcement:D-0901-2023

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #:2DV1863, 2HV2698, Exp. date 12/23; 2GV1583, Exp. date 02/24; 2GV1950, 2HV2697, Exp. Date 01/24.

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications