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The Department of Health (DH) today (December 12) endorses the recall of a batch of an anti-fungal medicine Eraxis for Injection 100mg ("Eraxis") (Registration number: HK-57097) by its product registration certificate holder, Pfizer Corporation Hong Kong Limited (Pfizer), due to quality issues.
DH announced to the public on November 23 that a joint Good Manufacturing Practice (GMP) inspection by European and US medicines regulatory agencies had discovered shortcomings in quality management system in the North Complex of the Ben Venue Laboratories﷿ (Ben Venue) manufacturing site in Ohio, USA. DH identified 13 registered pharmaceutical products manufactured by Ben Venue. Eraxis was one of the 13 products. According to Pfizer at that time, Eraxis manufactured by Ben Venue was not marketed in Hong Kong.
Subsequent to DH announcement in November, the European Medicines Agency (EMA) recommended a precautionary recall of Eraxis (known as Ecalta outside Hong Kong) as a result of the continuing review of the shortcomings in quality assurance identified in Ben Venue. DH was confirmed by Pfizer this afternoon that they had in fact imported a batch of Eraxis (Batch no: 0A7H5) in February 2010. There were a total of 2,000 boxes which had been distributed to the Hospital Authority, private hospitals, and also exported to Macao and other countries. The expiry date is January 2012.
Since the affected batch was manufactured by Ben Venue, Pfizer is recalling this batch from the market. Pfizer has set up a hotline (Tel: 2235 3245) to answer related enquiries.
DH will closely monitor the recall. DH investigation continues.
There is another registered product, namely "Eraxis Powder for injection 100mg", with different registration number: HK-59270 (manufactured by Pharmacia & Upjohn Company, USA) available in Hong Kong. It is not affected by the current recall exercise.
"Eraxis" is indicated for candidemia and other forms of Candida infections (such as intra-abdominal abscess and peritonitis). So far, no adverse event reports have been received concerning the drug.
DH spokesman adds, "Members of the public should stop using the batch under recall and should seek medical consultation if in doubt or feel unwell."
The DH has issued letters to healthcare professionals, the Hospital Authority, private hospitals and healthcare professional bodies to alert them of the product recall and not to supply the concerned product batch to their patients.
Ends/Monday, December 12, 2011
Issued at HKT 21:14
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