Lupin, Granules India Recall Diabetes Drug Metformin Hydroch
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Drugmakers Lupin and Granules India are recalling close to 9.71 lakh bottles of generic diabetes drug in the US due to the possibility of the affected lot containing cancer-causing nitrosodimethylamine (NDMA) above the acceptable intake limit.

• As per the USFDA, the companies are recalling the product due to deviation from the current good manufacturing practices (CGMP). "FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level," it noted.

• The USFDA has classified it as a Class-II recall, which 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".

• Lupin's recall in the US will not have an impact in the Indian market as the product sold here is manufactured at a separate facility.

• It could not be immediately ascertained if Granules India sells Metformin Hydrochloride extended-release tablets in the Indian market.

• Metformin Hydrochloride extended-release tablet is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus.

• Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits.

Source:https://www.deccanchronicle.com/business/companies/270720/lupin-granules-recall-971000-bottles-of-diabetes-drug-metformin-sup.html
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