April 09, 2020
Par Pharmaceutical Inc. is recalling nearly 30,000 bottles of glycopyrrolate tablets over the presence of an unknown impurity, according to the April 8, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count bottles of 1-mg glycopyrrolate tablets (NDC 49884-0065-01) manufactured by Par Formulations Private Limited. The recalled tablets are from lot 32809101 (Exp. 3/21) and were distributed in the United States.
Par Pharmaceutical voluntarily initiated the recall March 30, 2020. On the same day, 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.
Glycopyrrolate is a prescription anticholinergic medication used to treat peptic ulcers.