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Antihistamine Recalled


September 19, 2019

AvKare Inc. is recalling nearly 6000 bottles of fexofenadine hydrochloride tablets because they failed to meet stability specifications during testing, according to the September 18, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 180-mg fexofenadine hydrochloride tablets, 500 tablets per bottle (NDC 42291-297-50), from lots 067180011A (Exp. 4/21), 067180012A (Exp. 4/21), and 06718027B1 (Exp. 9/21). The recalled products were distributed within the United States. 

AvKare voluntarily initiated the recall August 28, 2019. The FDA designated the recall Class II on September 17, 2019, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Fexofenadine hydrochloride is an antihistamine used to treat allergy symptoms.

Jolynn Tumolo

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