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Recall Observatory FDA recall evidence

Drug product

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

D-0339-2022

July 27, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88384
Status
Terminated
Classification
Class II
Quantity
26,304 containers
Official record key
drug-enforcement:D-0339-2022

Official wording

Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Code information: Lot 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification