Drug product
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
D-0396-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,814 vials
- Official record key
drug-enforcement:D-0396-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: 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
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations