Drug product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.
D-0413-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,089 cartons
- Official record key
drug-enforcement:D-0413-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: R2101372, R2101397, R2101404, Exp. Date 4/30/2023; R2200264, R2200270, Exp. Date 8/31/2023; R2200382, Exp. Date 9/30/2023; R2200849, Exp. Date 12/31/2023; R2201017, R2201138, Exp. Date 1/31/2024; R2201249, Exp. Date 2/29/2024
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations