The Department of Health (DH) today (13 April) endorsed a licensed drug wholesaler, Hind Wing Co. Ltd ("Hind Wing"), to recall one batch (batch number: KW3889) of Apo-Pregabalin 50mg Capsules (HK-62682) and one batch (batch number: KL7884) of Apo-Verap SR 240mg Tablets (HK-59212) from shelf due to quality issue.
The DH received notification from Hind Wing that the Canadian manufacturer of the products had found an unidentified impurity out of specification in a batch of Apo-Pregabalin 50mg Capsules (batch number: KW3889) during a stability testing.
In addition, the Canadian manufacturer had also found a batch of Apo-Verap SR 240mg Tablets (batch number: KL7884) failed the dissolution test.
So far, the DH has not received any adverse reports in connection with the products concerned.. The DH has requested Hind Wing to liaise with the Canadian manufacturer to provide the detailed investigation report. DH’s investigation is continuing.
Apo-Pregabalin 50mg Capsules, containing pregabalin, is a prescription medicine used for the treatment of epilepsy and neuropathic pain. According to Hind Wing, 4 bottles of 100 capsules of the affected batch had been supplied to private doctors.
Apo-Verap SR 240mg Tablets, containing verapamil, is a prescription medicine used for the treatment of hypertension. According to Hind Wing, 96 bottles of 100 tablets of the affected batch had been supplied to private doctors.
Hind Wing has set up a hotline (2566 0562) to answer related enquiries. The DH will closely monitor the recall.
 |
| Related Information: |
| Canada: Recall: Apo-Risperidone Solution 1mg／ml Posted 2015-05-08 |
| Canada: Recall: APO-Candesartan 16 mg Posted 2015-05-05 |
| Recall of three batches of Apo-Fluoxetine 20mg Capsules Posted 2015-04-20 |
| Canada: Recall: Apotex Products – APO-Fluoxetine Capsules 20mg Posted 2015-04-18 |
| Canada: Recall: Apotex Products - APO-Candesartan 16mg, APO-Pregabalin 50mg, APO-Pregabalin 75mg and APO-Verap SR 240mg Posted 2015-04-13 |