Medicine recalls
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| Canada: Recall: APO-Fluoxetine Capsules 10mg and 20mg |
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Apotex Inc. is recalling two lots of APO-Fluoxetine 10mg (lot no.: MC5453 and KT8937), and APO-Fluoxetine 20mg (lot no.: KZ8596, KT8933, KT8935 and KT3278) as the active pharmaceutical ingredient (API) used in the manufacturing of these lots may not meet the specification for impurity – isobutyl vinyl ketone (IBVK). The depth of distribution of the products is retailers.
Health Canada classified the hazard level of the recall as Type II, i.e. a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../54834r-eng.php
In Hong Kong, Apo-Fluoxetine Cap 10mg (HK-41382) and Apo-Fluoxetine Cap 20mg (HK-41383) are pharmaceutical products registered by Hind Wing Co Ltd (Hind Wing). Related news on the recall of different lots of Apo-Fluoxetine 20mg had been issued by Health Canada, and was posted on the Drug Office website on 18 and 20 April 2015. According to Hind Wing, about 22,700 bottles of 100 capsules of Apo-Fluoxetine Cap 10mg (batch no.: MC5453 and KT8937) have been supplied to Department of Health (DH) clinics, Hospital Authority, private hospitals, private doctors and pharmacies since August 2014. About 2,160 bottles of 100 capsules of the Apo-Fluoxetine Cap 20mg (batch no.: KZ8596 and KT8933) have been supplied to private hospitals, private doctors and pharmacies since March 2014. On 26 August 2015, DH endorsed Hind Wing to initiate a recall of the affected batches of the products and a press statement was issued on the same day. So far, DH has not received any adverse drug reaction case related to the products. The recall is being closely monitored by DH.
Ends/ Tuesday, September 01, 2015
Issued at HKT 13:00
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