Tuesday, 26 January 2010

UNWHOLESOME DRUG ALERT-FDB

26-01-2010 UNWHOLESOME DRUG ALERT-FDB

The Food and Drugs Board (FDB) has ordered the recall of substandard Ciprofloxacin Tablets (500mg) USP, manufactured by GR Industries Limited, a pharmaceutical Company based in Accra. According to FDB, after the product was sampled and analysed through the FDB post market surveillance activities, it was found to be unwholesome. This was contained in a release signed by the Upper East Zonal Officer of FDB, Mrs. Rodgers Kwarteng and the Chief Executive Officer of FDB, Dr Stephen Opuni. The release outlined some of the quality defects of the product stating that it has no batch number and manufacturing dates on the primary and secondary packages. Also there is no date of expiry on the secondary package as well as the primary package. The product is said to have also failed to meet the USP requirement for dissolution for the tablets. It further stated that the product which is a pink paper carton and has its writing in white is not registered by the FDB. This, the release said, is in contravention of section 18 of the Food and Drugs Board Law (PNDCL 305B). The public is further informed that in view of the danger that non-compliance with existing regulatory measures pose to the public health and safety, the FDB shall not hesitate to seek the Minister’s approval for the closure of any facility that is found to be flouting the law. Meanwhile, FDB is compiling a list of unregistered products found on the market to be published for the information of the general public. The FDB has therefore ordered GR Industries Limited, Accra to recall their substandard Ciprofloxacin tablets from the market and submit a full recall report by the 29th January 2010. Additionally, information from the general public on persons suspected to be manufacturing illegally or in any practice possible of endangering public health and safety with respect to FDB’s mandate is most welcomed.

GBC END IA/EAD

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