Sun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination
Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for microbial contamination of injectable medication with no reported illnesses or injuries. The contamination of an injectable product represents inherent risk, warranting 'High' severity despite the absence of reported adverse events.
Plain-English summary
Decitabine for Injection is a chemotherapy medication for intravenous infusion, manufactured by Sun Pharmaceutical Ind. Ltd. (Halol, Gujarat, India) and distributed by Sun Pharmaceutical Industries Inc. (Cranbury, NJ). The recalled product consists of 2,088 single-dose vials containing 50mg each (lot HAD2964A, expiration 7/31/2024), distributed nationwide.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. The Total Aerobic Microbial Count (TAMC) test for the unfiltered bulk material was out of specification.
The recalled product
- Product
- 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…
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 2,088
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- HAD2964A
- Exp 7/31/2024
Distribution
Distributed nationwide across the United States.
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