November 08, 2018
Boehringer Ingelheim Pharmaceuticals Inc. is recalling 1380 bottles of Catapres (clonidine hydrochloride USP) 0.2 mg, according to the November 7, 2018, US Food and Drug Administration (FDA) Enforcement Report. During routine stability testing, an out-of-specification result occurred for impurities.
The recall affects 100-count bottles (NDC 0597-0007-01) from lot 757739 (Exp. 9/20). The bottles were distributed throughout the United States and in Puerto Rico.
Boehringer Ingelheim voluntarily initiated the recall October 22, 2018. On November 1, 2018, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.
Catapres is a prescription alpha-agonist hypotensive agent used to treat high blood pressure.
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