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FDA Recalls 3 Amlodipine / Valsartan Tablets   
 
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23-Jan-2019  
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The Foods & Drugs Authority (FDA) has recalled three Amlodipine/Valsartan contaminated tablets from the Ghanaian market.

The affected products are Amva Denk 10/160 Tablets (Amlodipine 10mg and valsartan 160mg), Amva Denk 5/160 Tablets (Amlodipine 5mg and valsartan 160mg), Amva Denk 5/80 Tablets (Amlodipine 5mg and valsartan 80mg.

The tablets were manufactured by Denk-Pharma GmbH & Co. KG.

The FDA claims the drugs have been affected with an impurity— N-nitrosodime (NDMA) — which has been detected above specification limits.

A statement issued by the FDA said, “The impurity which has been classified as a probable human carcinogen is found in active pharmaceutical ingredients (API) manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.”

The FDA further advised patients and healthcare professionals to be cautious when they are administered with such products.

“Healthcare professionals and patients are encouraged to be more vigilant when medicines and other health products and report any untoward events to the National Pharmacovigilance Centre, Food and Drugs Authority,” the statement indicated.

Meanwhile, patients have been asked not to stop taking the tablets unless they inform their doctor or pharmacist because not all tablets contain the NDMA impurity.

The FDA, in a related development, has issued a public alert on 42 cosmetic products containing substances that could pose potential health risk.

The FDA, as part of its routine market surveillance activity, found the possible adulteration of mercury, hydroquinone or steroids in some cosmetic products on the Ghanaian market.

The companies whose products contain these substances (mercury, hydroquinone and steroids) have been directed to initiate an immediate recall of their products from the market as they pose a potential health risk.

The affected companies are DIMD Limited, France Mod Limited, IVO Ghana Limited, Magic Dodo Limited, Paradise Cosmetics Limited, Stopover JRA Enterprise and Universal Basic Company Limited.

“These substances are not permitted in cosmetic products due to their adverse side effects over prolonged use which includes permanent neurological damage in children (pre-natal and neo-natal) exposed to mercury during pregnancy and or lactation, kidney toxicity, fertility problems, birth defects, gastrointestinal toxicity, liver toxicity, skin infections, skin cancer hyperpigmentation/ochronosis (‘Na ensoƐbƐn’) and skin infections,” the statement signed by James Lartey of  the Communications Department, FDA, revealed.

The FDA, therefore, advised the general public not to purchase any of the cosmetic products, immediately discontinue use and return all such products to the retail shops from where they were purchased or to the FDA and report to the FDA any adverse effects arising from the use of any cosmetic product through the FDA’s safety monitoring system.
 
 
Source: Daily Guide
 
 

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