Drug Enforcement D-0623-2025

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

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

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Product Information

Product description
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).
Product quantity
270,125 Vials
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
MS, OH, LA, and Puerto Rico

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0623-2025
Event ID
97510
Recall initiation date
August 27, 2025
Center classification date
September 8, 2025
Code info
Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
More code info
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