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Recall Observatory FDA recall evidence

Drug product

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4

D-0356-2022

July 27, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88384
Status
Terminated
Classification
Class II
Quantity
2,784 bottles
Official record key
drug-enforcement:D-0356-2022

Official wording

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

Code information: Lot # 1DV1855, exp 4/1/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification