Drug makers Lupin and Granules India have decided to recall close to 9.71 lakh bottles of generic diabetes drug in the US. They were forced to take this extreme step after the reports surfaced that the affected lot might contain cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit.
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Lupin is recalling 4,92,858 bottles of Metformin Hydrochloride extended-release tablets in 500 mg and 1,000 mg strengths.
On the other hand, Hyderabad-based Granules India is recalling over 4.78 lakh bottles of the drug in 750 mg strength.
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 sells Metformin Hydrochloride extended-release tablets under Gluconorm SR brand in India. The recall in the US will not have an impact in the Indian market as the product sold here is manufactured at a separate facility.
There are specific plants that cater to the US market. Granules India is recalling 4,78,173 bottles of the drug in the strength of 750 mg due to similar reasons.
The company’s US-based arm is recalling the affected lots which have been manufactured in India.
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.
FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation, but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.
N-Nitrosodimethylamine (NDMA)
N-Nitrosodimethylamine is a volatile, combustible, yellow, oily liquid nitrosamine with a faint characteristic odor that decomposes when exposed to light and emits toxic fumes of nitrogen oxides when heated to decomposition. N-Nitrosodimethylamine is primarily used in laboratory research to induce tumors in experimental animals.
This substance may be formed during the cooking of foods, especially cured meats and fish, that contain sodium nitrite as a preservative, but is also found in several vegetables, cheeses, alcoholic beverages and fruits, and as a contaminant in rubber products. Exposure to NNitrosodimethylamine irritates the skin and eyes and damages the liver. This substance is reasonably anticipated to be a human carcinogen. (NCI05)