Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo
Recalled March 8, 2023 · FDA recall D-0398-2023 · Accord Healthcare
Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
3,164 vials
Sold at
United States including Puerto Rico and Canada
Description
CGMP Deviations: recalling drug products following an FDA inspection.
Product
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →