FDAJuly 27, 2021drug

MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9

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

309046979609

Recall history

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

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