FDAJuly 27, 2021drug

TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

perrigo company plcperrigoperrigo company

UPCs

036800332843

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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