The Food and Drug Authority (FDA) has asked pharmaceutical importers and retailers to halt the importation and distribution of Galvus Met Tablets 50mg/1000mg manufactured by Novartis Pharmaceuticals, a Turkish company.
A statement issued by the FDA and signed by its CEO, Delese Darko, asked importers and retailers of the product to stop selling it and return all stock with batch codes KJM25, KLX74, KLY93, KLN34, KLP92, KLP93, KLR95, KLP38, and KLW59 to the nearest FDA office for safe disposal.
The statement said the medication, which had only Turkish inscriptions, lacked proper registration, “raising significant concerns about the unverified quality, safety, and efficacy of these pharmaceuticals.”
The Galvus Met Tablets 50mg/1000mg have been linked to suspected therapeutic failures and posed severe or life-threatening health risks, the FDA said.
It said the Authority had removed the product from the pharmacies where it was discovered.
The statement said the FDA was taking the necessary regulatory actions to prevent any future occurrence.
The FDA added, it would not hesitate to apply the strictest sanctions, including criminal prosecution and the imposition of administrative fines on any individual or facility found to be importing or distributing such products.
It assured the public of the integrity of its regulatory processes to ensure that medicinal and other regulated products registered for use on the Ghanaian market are safe, efficacious, and of the right quality.
