•Bans product administration to patients
By Miriam Humbe
The National Agency for Food and Drug Administration and Control (NAFDAC) in exercise of its powers, recently announced a recall of Valsartan, an anti-hypertension medication.
This recall 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.
According to Director-General of the Consumer Protection Council, Babatunde Irukera, 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.
Irukera said, “In furtherance of the prohibition and recall affecting importers, distributors, retail pharmacies, and continuing prescription, the Consumer Protection Council (CPC) advises 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.
“The Council encourages 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 further advises distributors of this product(s) of their statutory obligation to notify the public of the risks associated with consumption and immediate withdrawal from the market, pursuant to Section 9(1) of the Consumer Protection Council Act. Violation of this obligation is an offense liable to a term of imprisonment upon conviction.
“In the interim, the Council is taking steps to identify all such importers and distributors to ensure their full compliance with the law”.