D-0582-2024 Class II Ongoing
FDA drug recall D-0582-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on July 2, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. The recall status is ongoing. Affected quantity: 2088 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2024
- Initiation Date
- July 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2088 vials
Product Description
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.
Reason for Recall
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Distribution Pattern
Nationwide in the USA
Code Information
HAD2964A, Exp 7/31/2024