Saturday, Aug 08, 2020 | Last Update : 09:23 AM IST

136th Day Of Lockdown

Maharashtra49026232728117092 Tamil Nadu2850242275754690 Andhra Pradesh2069601204641842 Karnataka164924842322998 Delhi1427231282324082 Uttar Pradesh113378668341981 West Bengal89666630601954 Telangana7525753239601 Bihar7179446294400 Gujarat68855517922604 Assam5549737225132 Rajasthan4941835186763 Odisha4255028698292 Haryana4005433444467 Madhya Pradesh3729827621962 Kerala3170019147103 Jammu and Kashmir2392716218449 Punjab1901512491462 Jharkhand140705199129 Chhatisgarh10109761369 Uttarakhand8008484795 Goa7075511460 Tripura5520367528 Puducherry4147253758 Manipur301818147 Himachal Pradesh2879171013 Nagaland24056594 Arunachal Pradesh179011053 Chandigarh120671520 Meghalaya9173305 Sikkim7832971 Mizoram5022820
  Business   Companies  27 Jul 2020  Lupin, Granules recall 9,71,000 bottles of Metformin supplied to US

Lupin, Granules recall 9,71,000 bottles of Metformin supplied to US

PTI
Published : Jul 27, 2020, 8:58 am IST
Updated : Jul 27, 2020, 8:58 am IST

Hyderabad-based Granules India is recalling over 4.78 lakh bottles of the drug in 750 mg strength

 Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US market. (Representative Image)
  Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US market. (Representative Image)

New Delhi: Drug makers Lupin and Granules India are recalling close to 9.71 lakh bottles of generic diabetes drug in the US due to possibility of the affected lot containing 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 is recalling 1,23,912 bottles of the 500 mg Metformin Hydrochloride extended-release tablets and 3,68,946 bottles of the same drug of 1,000 mg strength.

The product has been manufactured at Lupin's USFDA approved Goa-based manufacturing plant, and is being recalled by company's US based subsidiary.

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.

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.

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.

 

NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and food, including meats, dairy products and vegetables.

Tags: lupin, granules india, diabetes drug, us, usfda, ndma, diabetes
Location: India, Delhi, New Delhi