Granules recall twelve lots of Metformin Hydrochloride ER tablets

Granules Pharmaceuticals, Inc., (Chantilly, Virginia), which is a wholly-owned subsidiary of Granules India Limited, has voluntarily recalled 12 lots of Metformin Hydrochloride extended-release tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake (ADI).

Granules test results showed that NDMA levels in one of the 12 batches distributed to the US market were above the accepted Food and Drug Administration (FDA) levels. Based on laboratory testing, NDMA is classified as a probable human carcinogen, which means it contains a substance that could cause cancer. Hence, the company has recalled the 12 distributed lots from the market as a precautionary measure.

In clarification, the company mentioned that Metformin Hydrochloride immediate-release tablets USP, 500 mg, 850 mg & 1,000 mg and Metformin Hydrochloride extended-release tablets USP, 500 mg are not affected by this recall. In the press release, the company also attached a product photo for easy recognition. As of now, no reports of any adverse events related to this, have been reported to the company.

On Friday, the stock of the company closed at Rs 208.40, up by 0.31 per cent or Rs 0.65 per share. The 52-week high is Rs 224.60 and the 52-week low is Rs 84.25 on BSE.