FDAHealthAugust 27, 2025
Zydus Pharmaceuticals (USA) Inc — 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;
⚠️ Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Is this relevant to me?
- Geography
- MS, OH, LA
- Source agency
- FDA
- Category
- Health
- Published
- August 27, 2025
MS, OH, LA, and Puerto Rico
What's affected?
- 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).
- Lot code
- L400077
Additional details
Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 270,125 Vials.
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