FDA recall D-0623-2025

Zydus Pharmaceuticals (USA) Inc · Class II · 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).

Reason for recall

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

Distribution

MS, OH, LA, and Puerto Rico

Key facts

Status
Ongoing
Initiation date
2025-08-27
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2025