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Press Release

Voluntary recall of Zithromax Powder for Oral Suspension 200mg/5ml because of suspected quality defect

12 May 2010

The Department of Health (DH) was informed today (May 12) by Pfizer Corporate Hong Kong Ltd ("Pfizer") , a licensed drug wholesaler, that the company is recalling one batch of Zithromax Powder for Oral Suspension 200 mg/5ml registration number (Registration No. HK-36432, Batch no: 96415502) from the market in view of its possible quality defect.

The recall was made after Pfizer has received two complaints in Hong Kong concerning the captioned batch of Zithromax Powder for Oral Suspension 200mg/5ml, in where black particles were found.

According to Pfizer, the product was manufactured in Italy. So far, investigations by Pfizer suggested that the product was likely to be contaminated with rubber particles, with an average size of 0.27mm.

Zithromax Powder for Oral Suspension 200ml/5ml is an antibiotic used for various infectious diseases. It can only be sold in pharmacies on a doctor's prescription and under the supervision of a pharmacist.

According to Pfizer's information in hand, around 39,000 boxes of the affected batch were imported into Hong Kong. Among them, 33,000 boxes have been supplied to public and private hospitals, private doctors and pharmacies. Some were exported to Macao. DH's investigation continues.

A DH spokesman explained that although the findings so far pointed to quality defects, nevertheless, Pfizer opted to initiate a voluntary recall as a precautionary measure as the product is commonly used in children - a vulnerable group. On assessment, the DH endorsed Pfizer's decision and will closely monitor the exercise and the development.

Pfizer has set up a hotline, 2590 8082, for public enquiries.

The DH spokesman urged healthcare professionals and retailers to stop supplying the product to their clients. "People who have used the product should consult healthcare professionals if in doubt," he said.

12 May 2010