Drug product
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 0
D-0399-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 322 vials
- Official record key
drug-enforcement:D-0399-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: R2200431, Exp. Date 7/31/2023, R2200439, Exp. Date 9/30/2023
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations