Drug product
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
D-0623-2025
Product summary
- Event
- Event 97510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 270,125 Vials
- Official record key
drug-enforcement:D-0623-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Code information: Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
Distribution pattern: MS, OH, LA, and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-Specification