22 Oct 2010
The Department of Health (DH) instructs Neochem Pharmaceutical Laboratories Ltd (Neochem), a licensed drug manufacturer, to recall from the market 42 batches of 37 registered products as they were produced when the plant was not licensed to manufacture.
Between March and July 2010, Neochem had recalled, on four occasions, five products from the local market because all were found to have insufficient active ingredients.
Subsequently, the Pharmacy and Poisons (Manufacturers Licensing) Committee (the Committee) of the Pharmacy and Poisons Board suspended Neochem's manufacturer licence in April 2010. The licence was fully restored in September after Neochem satisfied the Committee that it was in compliance with Good Manufacturing Practices (GMP).
Recently, through its surveillance system, DH found that Neochem had actually produced between July and August, without licence, 42 batches of 37 registered products. As such, the safety, efficacy and quality of the products cannot be guaranteed. Hence, DH instructed a recall today (October 22).
Products under recall are listed out in the annex .
Since detail arrangements of the recall will be announced by Neochem on October 25, the spokesman urged healthcare professionals and retailers to stop supplying the products and clients with the products in hand to stop using them immediately.
It is noted that the manufacturer has set up a hotline at Tel 3427 3525 to answer enquiries during office hours. DH will monitor progress of the recall closely.
He said, “Members of the public who have used the products should consult healthcare professionals if in doubts.”
In connection, DH will consult the Department of Justice on possible legal actions and the issue will also be discussed in the Committee’s next meeting for possible disciplinary actions.