The Consumer Protection Council (CPC) has reminded distributors of Valsartan, an anti-hypertension medication that has been recalled in many countries including Nigeria of their statutory obligation to notify the public of the risks associated with consumption of the drug and its immediate withdrawal from the market, pursuant to Section 9(1) of the Consumer Protection Council Act. The agency said a violation of this obligation is an offense liable to a term of imprisonment upon conviction.
A statement signed yesterday by director general of the agency, Mr Babatunde Irukera, said the recall of the drug was based on notification from the United Kingdom authorities about the potential contamination of Valsartan tablets, manufactured by Accord Healthcare, previously known as Actavis Group. Currently 22 countries including the European authorities and United States have also recalled Valsartan.
“Pursuant to Section 2 (b), (c) (e) and 9 of the Consumer Protection Council Act 2004, the National Agency for Food and Drug Administration and Control (NAFDAC) in exercise of its powers announced a
recall of Valsartan, an anti-hypertension medication.
“NAFDAC directed all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of these products. NAFDAC further directed that healthcare providers should stop the administration of these products to patients because the drug is contaminated with genotoxic and carcinogenic potentials on account of changes in the manufacturing process of the active substance manufactured in China.
“Specific products included are; all Valsartan drugs in 40mg, 80mg, 160mg capsules and film coated tablets of 40mg, 80mg, 160mg and 320mg,” the Council stated.
It therefore advised all persons currently under high blood pressure medication or hypertensive care to check their medications and ask questions of relevant professionals to ensure immediate discontinuation of the affected drugs; if currently under the administration of the same.
It also encouraged citizens to conduct the necessary inquiries with respect to family members who may be taking this medication but may be unaware of the recall, or this advisory.
The Council said in the interim, it was taking steps to identify all such importers and distributors to ensure their full compliance with the law.
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