Class II
Ongoing
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
This recall is currently active, issued July 10, 2024. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- July 2, 2024
- Posted
- July 10, 2024
- Recall Number
- D-0582-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2088 vials
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Distribution
Nationwide in the USA
Lot / Code Info
HAD2964A, Exp 7/31/2024
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