This recall involves 2,088 vials of Decitabine for Injection (50mg per vial), a chemotherapy medication distributed by Sun Pharmaceutical Industries, Inc. The product is being recalled because manufacturing tests showed microbial counts that exceeded safety specifications for the unfiltered bulk product. The affected medication is from lot HAD2964A and has an expiration date of July 31, 2024.
Because this medication is a sterile injectable administered directly into the bloodstream, the presence of microbes poses a serious risk of infection and other systemic health complications for patients.
Distributed by Sun Pharmaceutical Industries, Inc. (Cranbury, NJ); Manufactured by Sun Pharmaceutical Ind. Ltd. (Gujarat, India). Recall number D-0582-2024.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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