Medicine recalls
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| Voluntary recall of Treanda® (bendamustine HCL) for Injection 25mg/vial (lot number TB30411) by Cephalon, Inc. due to an out of specification result for one of the impurities |
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Department of Health has been informed by Cephalon, Inc. that the company in the United States has voluntarily recalled a single batch of Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30411, expiration date 3/2013. Treanda® (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of chronic lymphocytic leukemia. This product lot is being recalled due to the reporting of an Out of Specification (OOS) result for one of the impurities; BM1-DCE. The OOS was discovered during testing at a long term stability time point. The BM1-DCE is one of the degradation products of bendamustine HCL. The health hazard for the impurity Out of Specification is considered low. No adverse events reports have been received that can be attributed to the impurity Out of Specification condition.
In Hong Kong, the above product is not a registered pharmaceutical product. Department of Health will keep vigilant against any updated safety news of the drug.
Ends/ Thursday, March 29, 2012
Issued at HKT 12:30
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