Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Status
Terminated
Lot
Batches: R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Accord Healthcare, Inc. — Class II Recall | MedicineWatch US