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FDB recalls drugs from the market
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General News of Wednesday, 10 March 2010

Source: GNA

FDB recalls drugs from the market

Accra, March 10, GNA - Food and Drugs Board (FDB) has ordered the recall of substandard Cipro-Dor (Ciprofloxacin Hydrochloride equivalent to 500mg Ciprofloxacin) and Clavu-Dor (Amoxicillin 500mg and Clavulanic Acid 125mg) tablets which were manufactured by two Chinese companies and found to be unwholesome from the market.

A statement issued in Accra on Wednesday and signed by Dr Stephen K. Opuni, Chief Executive Officer, provided details of the medicines, the manufacturing companies and the quality defects detected in the FDB Laboratory.

The details are as follows; Cipro-Dor 500MG tablets, manufactured by Shijazhuang Pharmaceutical Group, Ouyi Pharma Company Limited, China. The batch number is 08C0701 and the manufacturing date is July, 2008 (07/08) and the expiry date is July, 2011 (07/11) and the quality defect is failed assay, (ciprofloxacin content) and dissolution. The statement said the second product, Clavu-Dor 625MG tablets was manufactured by Shandong Reyoung Pharmaceutical Company limited, China The batch number is 071201 with manufacturing date as December 2007 (12/07) and expiry date of December 2010 (12/10) while the quality defect was failed Clavulanic Acid assay (Clavulanic Acid content) and dissolution rate. It said the products, which were sampled and analyzed through the FDB Post Market Surveillance activities, were antibiotics used to treat severe life threatening infections.

The Cipro-Dor tablets are used to treat; Typhoid Fever; Urinary Tract Infections; Pelvic Organ Infections and Bone and Joint Infections. The Clavu-Dor tablets are used to treat; Upper Respiratory Tract Infections; Dental Infections; Lower Respiratory Tract Infections and Skin and Soft Tissue Infections.

The statement said these were in contravention of Section 14 of the Food and Drugs Law (PNDCL 305B, 1992) and its subsequent amendment Act 523 (1996), which states that:

"Any person who labels, packages, sells or advertises any drug, cosmetic, medical device or household chemical in contravention of any regulations made under this Law, or in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merits or safety, commits an offence". It said laboratory analysis conducted on samples submitted for registration by the two companies conformed to their respective specifications (of the right quality) according to which they were manufactured and therefore the products were registered and permitted to be sold on the Ghanaian market.

However, as normally done by the FDB through its post market surveillance activities, samples of antibiotics picked from pharmacy shops nationwide and analyzed at the FDB laboratory included Cipro-Dor and Clavu-Dor, which were found to be substandard.

"Looking at the indications stated above (i.e. diseases that the said medicines are expected to treat), any patient who has been prescribed (placed on) these medications may be at a high risk since these medicines cannot cure the diseases for which they were prescribed because they are substandard.

"The FDB has therefore ordered the recall of these substandard antibiotics (Cipro-Dor 500mg and Clavu-Dor 625mg) immediately from the market. The substandard Cipro-Dor and Clavu-Dor will be destroyed under the FDB's supervision", it added. The management of FDB assured consumers that it would continuously monitor the quality of regulated products (under its mandate) on the market and take the appropriate regulatory actions whenever substandard products were detected.

Additionally, it said any information from the public on persons suspected to be manufacturing or importing illegally or in any practice possible of endangering public health and safety with respect to FDB's mandate was most welcome through any of the following contact numbers: 0244337235 and 0244385086. 10 March 10

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