Medicine recalls
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| Canada: Rifadin (rifampin capsules USP) 150mg - Voluntary Recall of One Lot Due to Capsules Under Fill Weight |
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Sanofi-aventis Canada Inc. (Sanofi Canada) in consultation with Health Canada, would like to inform healthcare professionals of a voluntary recall of one lot (lot 3099036) of Rifadin® (rifampin capsules USP), 150 mg, bottle of 100 capsules with an expiration date of March 2014, to the retail level, due to finding under fill weight capsules in retain samples. Rifadin® is indicated in the treatment of tuberculosis and in the prophylaxis of bacterial meningitis or carriage of N. meningitidis or H. influenza b in persons exposed to a primary case. Rifadin® is available in 150 mg and 300 mg capsules.
Following a review of a limited number of Rifadin® retain samples, a low number of 150 mg capsules (2 - 3%) were found to have a low fill weight. Based on this information, Sanofi Canada has decided to initiate a voluntary recall of the single lot impacted (lot 3099036) as a precautionary measure. The probability of adverse health consequences for the patients for the approved indications is low. Nonetheless, there is a potential risk of patients having received a lower dose if they were treated with Rifadin® capsules 150 mg from lot 3099036. Sanofi Canada would like to remind the healthcare professionals to monitor their patients carefully, particularly those who might have received Rifadin® 150 mg capsules from this lot for the prophylaxis of bacterial meningitis. Any remaining stock of the recalled lot must be returned to Sanofi Canada. Other lots of Rifadin® 150 mg capsules and Rifadin® 300 mg capsules are not affected by this recall.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../26171a-eng.php
In Hong Kong, Rifadin Cap 150mg (HK-28162) is registered by Sanofi-Aventis Hong Kong Limited (Sanofi-Aventis) and is a prescription-only medicine. Confirmed with Sanofi-Aventis, the affected batch has not been imported into Hong Kong.
Ends/ Wednesday, March 20, 2013
Issued at HKT 12:00
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