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.
The company has now filed before the exchange, clarifying that there has been no additional recall post the press release.
"Granules Pharmaceutical Inc. (GPI), Chantilly, VA, a wholly-owned subsidiary of Granules India Limited, would like to clarify that there has been no additional recall post the press release, dated July 3rd, 2020, also attached herewith. As mentioned in that press release, Granules did a voluntary recall of 12 batches of 750mg of the generic Metformin ER," Granules said.
"Only 1 (One) batch out of a total of 12 (Twelve) did not meet the specifications, but all the batches of 750mg were pulled out on the abundance of caution. The 750mg constitutes less than 8% of the total volume of Generic Glucophage ER (Reference Listed Drug) as per IQVIA data and constituted 0.3% of the total revenue of the company as per the year ended FY 20," the company added.