The food and Drugs Board (FDB) has ordered the recall of substandard Ciprofloxacin tablets (500 mg) USP produced by GR Industries Limited in Accra because they have been found to be unwholesome.
A statement signed by its Chief Executive Officer, Dr Stephen K. Opuni, and issued by the board in Accra yesterday, said the product had no batch number and manufacturing dates on both the primary and secondary packages.
Additionally, the product has not legible date of expiry on the primary package and no date of expiry on the secondary package. Furthermore, the statement said, �The product failed laboratory analysis (failed to meet the USP requirement for dissolution for the tablets).�
Consequently, the board ordered GR Industries Limited to recall its substandard Ciprofloxacin tablets from the market and submit a full recall report by January 29, 2010.
The statement said the product was sampled and analysed through FDB�s post-market surveillance activities. It said �the product, which is in a pink paper carton and has its writings in white, is not registered by the FDB�.
The statement said the non-registration of the drug was in contravention of Section 19 of the Food and Drugs Law (PNDCL 305 B) and its subsequent amendment Act 523 1996 which states, �No person shall manufacture, prepare, sell supply, export or import into Ghana any drug, cosmetic, medical device or household chemical unless the article has been registered with the Food and Drugs Board.�
It said in view of the danger that non-compliance with existing regulatory measures posed to public health and safety, the FDB would not hesitate to seek the minister�s approval for the closure of any facility that was found to be flouting the law.
Meanwhile, the statement said the FDB was compiling a list of unregistered products found on the market (including the names of the manufacturers or importers) to be published for the information of the public.
Additionally, it said information from the public on persons suspected to be manufacturing illegally or in any practice possible of endangering public health and safety could report to the FDB on the following telephones: 0244337235, 0244337243, 0244337251 or 0244337252.
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