Medicine recalls
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| Canada: Recall: PMS-Rosuvastatin 40mg |
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Health Canada announced the recall of two lots of Rosuvastatine (Rosuvastatin Calcium) 40 mg, lot no.: 482560 (Bottle of 100 Tabs) and 481460 (Blister packaging) due to out of specification results in the stability testing for impurity degradation. The products were distributed to wholesalers and retailers.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../43243r-eng.php
In Hong Kong, PMS-Rosuvastatin Tablets 40mg (HK-61934) is a prescription-only medicine registered by Trenton-Boma Ltd. (T-Boma). T-Boma has notified the Department of Health (DH) about the incident and proposed the recall of the affected batch (only batch 481460 was available in Hong Kong). According to T-Boma, the manufacturer found out, during the stability study, that the samples of the affected batch contained a degradated impurity exceeding the specification limit. 46 boxes of the batch 481460 had been supplied to private doctors and pharmacies since September 2014. The DH endorsed T-Boma to initiate a voluntary recall of the affected batch of the product, and posted the related announcement on the Drug Office website on 6 January 2015. T-Boma confirmed that the batch 482560 has not been imported into Hong Kong. So far, the DH has not received any adverse drug reaction report in relation to the product and has been notified by T-Boma that the recall of the product has been completed.
Ends/ Friday, January 09, 2015
Issued at HKT 17:00
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