Class II
Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
This recall is currently active, issued March 12, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- February 13, 2025
- Posted
- March 12, 2025
- Recall Number
- D-0256-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,893 vials
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
USA Nationwide
Lot / Code Info
Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
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