Press Release

Recall of three batches of Apo-Fluoxetine 20mg Capsules

20 April 2015

The Department of Health (DH) today (April 20) endorsed a licensed drug wholesaler, Hind Wing Co. Ltd (Hind Wing), to recall three batches (batch number: KT8932, KZ8595 and ME3862) of Apo-Fluoxetine 20mg Capsules (registration number: HK-41383) at retailer level due to potential safety issue.

Through the DH's surveillance system, it was noted that Health Canada, drug regulatory authority in Canada, announced a batch recall of Apo-Fluoxetine 20mg capsules because the active pharmaceutical ingredient used in the manufacturing of the affected batches may not meet the specification for the impurity (isobutyl vinyl ketone).

So far, the DH has not received any adverse reports in connection with the concerned product. The DH has requested Hind Wing to liaise with the Canadian manufacturer to provide further information regarding the incident and a detail investigation report.

DH's investigation is continuing.

Apo-Fluoxetine 20mg Capsules, containing fluoxetine, is a prescription medicine used for the treatment of major depressive disorder. According to Hind Wing, about 2727 bottles of 100 capsules of the affected batches have been supplied to private doctors and pharmacies since March 2014.

Hind Wing has set up a hotline (2566 0562) to answer related enquiries.

DH will closely monitor the recall.

"Healthcare professionals and pharmacies are advised to stop supplying the affected batches of the product to patients. Members of the public who are taking the product should consult their doctors for advice," a DH spokesperson advised.