Granules India clarifies on recall of 4.78 lakh bottles of Metformin Hydrochloride ER tablets in US
Hyderabad: Over the past weekend, there were several media sources that claimed that Granules India recalls 4.78 lakh bottles of diabetes drugs- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 in the US. The drugmaker has now furnished a clarification in response to the same; wherein, it denied any such news and stated that there has been no additional recall post the press release, dated July 3rd, 2020.
As per the media report, Granules Pharmaceuticals, Inc., Chantilly, VA had voluntarily recalled twelve (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 NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.
Granules' test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. Out of an abundance of caution Granules Pharmaceuticals, Inc. had decided to voluntarily recall all twelve (12) of the distributed lots within the expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market, the company stated in its press release.
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