February 19, 2021
Accord Healthcare Inc is voluntarily recalling 502 cartons of glycopyrrolate injection. According to the February 17, 2021, US Food and Drug Administration (FDA) Enforcement Report, 2-mL vials of glycopyrrolate were packaged into blister strips labeled for 1-mL vials.
The recall affects glycopyrrolate injection, 0.4 mg/2 mL (0.2 mg/mL), 25 x 2-mL single-dose vials (carton NDC 16729-472-08, vial NDC 16729-472-30), from lot M2013645 (Exp. 8/22). The product was manufactured by Intas Pharmaceuticals Limited for Accord Healthcare and distributed throughout the United States.
The recall was initiated by Accord Healthcare on January 28, 2021, and designated Class III by the FDA on February 8, 2021. Under the recall classification, use of the product is not likely to cause harm.
Glycopyrrolate injection is a prescription anticholinergic used during anesthesia or as adjunctive therapy for the treatment of peptic ulcer in adults.