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Press Release

Batch recall of Apo-Fluoxetine 10mg and 20mg Capsules

26 August 2015

The Department of Health (DH) today (August 26) endorsed a licensed drug wholesaler, Hind Wing Company Limited (Hind Wing), to recall respectively two batches (batch numbers: KT8937 and MC5453) of Apo-Fluoxetine 10mg Capsules (registration number: HK-41382) and two batches (batch numbers: KT8933 and KZ8596) of Apo-Fluoxetine 20mg Capsules (registration number: HK-41383) at retailer level due to potential safety issue.

Following the recall of Apo-Fluoxetine 20mg Capsules on April 20 , Hind Wing today notified DH that the manufacturer in Canada is recalling further batches of the products because the active pharmaceutical ingredient used in the manufacturing of the affected batches may not meet the specification for the impurity (isobutyl vinyl ketone). Investigation by the manufacturer found that the cause of the impurity was due to lack of temperature controls during the synthesis process.

So far, the DH has not received any adverse reports in connection with the concerned products. DH's investigation is continuing.

Apo-Fluoxetine 10mg and 20mg capsules, both containing fluoxetine, are prescription medicines used for the treatment of major depressive disorder.

According to Hind Wing, about 22,700 bottles of 100 capsules of the affected batches of Apo-Fluoxetine 10mg Capsules have been supplied to DH clinics, Hospital Authority, private hospitals, private doctors and pharmacies since August 2014. About 2,160 bottles of 100 capsules of the affected batches of Apo-Fluoxetine 20mg Capsules have been supplied to private hospitals, 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 products to patients. Members of the public who are taking the products should consult their doctors for advice," a DH spokesperson advised.

Four batches of Apo-Fluoxetine 10mg and 20 mg Capsules are under recall, as endorsed by the Department of Health.

26 Aug 2015