Muscat: The Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC), the supervisory authority in Oman, has evaluated the information received from the US drug authorities regarding the recall of some batches of substances containing metformin used in the treatment of diabetes, due to lack of conformity with the technical specifications.
“Their investigations revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake limit,” a statement from the Ministry of Health said.
The withdrawn batches in the US are non-marketed in the Sultanate however, as a precautionary action the DGPA&DC contacted all metformin manufacturers registered in the country to ensure appropriate testing to prove the absence of these impurities in their products or if detected are at acceptable levels. DGPA&DC is further following up closely with any updates in this regard and that appropriate procedure will be taken to ensure the safety and security of medications in the local market.
Hence, the Directorate calls on patients to continue taking metformin tablets. It further urges all members of society and health providers to report any adverse effects of medicines or for any inquiries contacting the Department of Pharmacovigilance & Drug Information on 51 22357687/ 22357686 12 22358489