Recall one batch of Pan-Benzathine Pen G For Inj 1.2miu/Vial (HK-45748) The Department of Health (DH) today (February 6) endorsed a licensed drug wholesaler, LF Asia (Hong Kong) Limited - Universal Division (LF Asia), to conduct a voluntary recall of one batch (batch number: 301299) of Pan-Benzathine Pen G For Inj 1.2miu/Vial (HK-45748) from the market due to potential quality issue.
DH received notification from LF Asia today that the French manufacturer of the product, Laboratoires Panpharma, has reported that non-compliance with Good Manufacturing Practice (GMP) was observed by the French drug regulatory authority on the manufacturer of active pharmaceutical ingredients in mainland China. Although no specific risk has been identified so far, such non-compliance may pose potential risk to the quality of the product; and hence the recall is conducted by the French manufacturer as a precautionary measure. The above batch of product is the only available batch in the market. The DH has requested LF Asia to provide a detailed investigation report as soon as possible.
Pan-Benzathine Pen G For Inj 1.2miu/Vial containing benzathine penicillin is an antibiotic injection indicated for the treatment of infections. It can only be supplied at pharmacies under the supervision of registered pharmacist upon doctor's prescription.
According to LF Asia, 3000 vials of the affected batch were imported to Hong Kong in September 2013. Among the imported stock, around 2336 vials have been supplied to private and HA hospitals, DH clinics, private doctors and pharmacies. The remaining 664 vials are now quarantined. So far, the DH has not received any adverse reports in connection with the product. The DH's investigation is continuing.
LF Asia has set up hotlines (2562 3231) to answer related enquiries. The DH will closely monitor the recall.
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