Drug 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
D-0398-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,164 vials
- Official record key
drug-enforcement:D-0398-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations