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The Department of Health (DH) today (November 24) instructed licensed drug manufacturer Marching Pharmaceutical Ltd (Marching) to recall two products, namely Marsedyl Elixir and Prophenin Elixir, from the market because the shelf-life of the products were changed without approval.
Marsedyl Elixir and Prophenin Elixir were originally registered with the Pharmacy and Poisons Board of Hong Kong (PPB) under the registration numbers HK-21197 and HK-32517 respectively. However, the products being sold by Marching have a shelf-life different from that registered, which renders the products unregistered under the Pharmacy and Poisons Regulations, Cap. 138A.
"The incident came to light during a routine DH inspection against Marching. It was found that the company has changed the shelf-life of both Marsedyl Elixir and Prophenin Elixir to six-month while the products registered with the PPB have a two years' shelf-life. Since the change is not approved by the PPB, the products are unregistered and must be recalled. DH investigation continues," a DH spokesman said.
Both Marsedyl Elixir and Prophenin Elixir have the same formulation and they contain promethazine, codeine and ephedrine. They are used for the symptomatic treatment of cough and cold. They could only be sold under the supervision of pharmacists at registered pharmacies. According to the records of Marching, about 400,000 bottles of the two products were supplied to local pharmacies.
Marching has set up a hotline 2781 6323 for public enquiries.
The spokesman said: "Selling unregistered pharmaceutical products is an offence and the offenders, upon conviction, will be subject to a maximum penalty of $100,000 and two years' imprisonment."
"Pharmacies must stop supplying the said products to clients. Members of the public who are taking the above medicines should stop taking them and seek advice from healthcare professionals when in doubt," the spokesman urged.
Ends/Thursday, November 24, 2011
Issued at HKT 19:57
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