Sun Pharma is recalling 50,868 bottles of diabetes drug Metformin HCl extended-release tablets in the US market, according to the US Food and Drug Administration (USFDA).
The US-based arm of the drug firm is recalling the affected lot of 500 mg tablets (in 500 count bottles) due to “presence of foreign substance identified as activated carbon,” as per the latest Enforcement Report issued by the US health regulator.
The tablets were produced at the company’s Halol (Gujarat) based manufacturing plant and later distributed in the US by Cranbury (NJ) based Sun Pharmaceutical Industries.
The USFDA has classified the voluntary recall undertaken by the company as a class II recall.
As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Sun Pharmaceutical Industries has initiated the nationwide recall on May 4 this year.
(Edits by EP News Bureau)