The Foods and Drugs Authority (FDA), has recalled three Amlodipine/Valsartan contaminated tablets from the market.
This is because the drugs have been affected with an impurity, N-nitrosodime (NDMA), which has been detected above specification limits.
The FDA has initiated the recall of the under-listed Amlodipine/Valsartan Combination Tablets manufactured by Denk-Pharma GmbH & Co. KG due to contamination with a
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
In a statement issued by the FDA, it 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 Authority further advises 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.”
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.
Healthcare professionals have also been advised to return the medicine to their wholesale supplier.
By: citinewsroom.com |Ghana