February 28, 2020
Two lots of glycopyrrolate tablets and vials are being recalled by two separate firms because samples failed to meet impurity specifications during testing, according to the February 26, 2020, US Food and Drug Administration (FDA) Enforcement Report.
NCS Healthcare of Kentucky issued a voluntary recall for glycopyrrolate tabs, 1 mg, 30-count unit dose blister cards for institutional use (NDC 0615-8170-39), on January 28, 2020. The recall affects tablets from lot 8170-9004 (Exp. 1/20). The blister cards, which were packaged by Vangard, were distributed throughout the United States. On February 18, 2020, the FDA designated the recall Class II, suggesting use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
On February 7, 2020, AuroMedics Pharma issued a voluntary recall for glycopyrrolate injection, 4 mg per 20 mL (0.2 mg/mL), 20-mL multiple-dose vials (NDC 55150-295-20). The recall affects vials from lot CGP190001-A (Exp. 7/31/20), which were distributed in Ohio, Louisiana, and Mississippi. The FDA designated the recall Class III on February 20, 2020, signaling use of the product is not likely to cause harm.
Glycopyrrolate is a prescription long-acting muscarinic antagonist and anticholinergic gastrointestinal antispasmodic medication. The tablets are used to treat patients with peptic ulcers, and the injection is used treat gastrointestinal ulcers or, during surgery, to reduce saliva and other secretions.