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
Reported: March 12, 2025 Initiated: February 13, 2025 #D-0256-2025
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 1,893 vials
- Distribution
- USA Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 1,893 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 12, 2025. Severity: Moderate. Recall number: D-0256-2025.
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