FDB orders withdrawal of antibiotic

Accra, Jan. 21. GNA - The Food and Drugs Board (FDB) on Thursday ordered the immediate withdrawal of an antibiotic, Ciprofloxacin (500mg) tablets, from the markets by January 29.

FDB said in a statement that the medicine was sub-standard, unwholesome and posed a danger to the health and safety of the people since it failed to comply with the existing regulatory measures. The medicine manufactured by GR Industries Limited based in Accra, did not have a batch number on the primary and secondary packages, no manufacturing dates and no legible date of expiry on the primary packages and the secondary package. It also failed all laboratory analysis.

The statement signed by Dr Stephen Opuni, Chief Executive of FDB, said the product, which was in a pink carton, and had its writings in white, was sampled and analysed through the FDB's post-market surveillance activities. The release noted that the production of the drug contravened section 18 of the FDB's law (PNDCL305B) and its subsequent amendment Act 523 1996.

"The FDB shall not hesitate to seek the Minister's approval for the closure of any facility that would be found to be flouting the law." FDB said it was compiling a list of unregistered products found on the market to be published for the information of the general public. 21 Jan. 10