I was told that metformin hydrochloride 500 mg and 700 mg tablets manufactured by a number of companies were recently recalled by FDA due to carcinogenic ingredient contained in it.Can anyone clarify whether GLYCOMET 500SR tablets(Metformin hydrochloride sustained release tablets IP 500Mg) manufactured by USV P rivate Limited , Himachal Pradesh, India were also recalled. My wife is taking this medicine for the last several years and want to discontinue, if there is risk
Is Glycomet 500SR safe: I was told that... - Diabetes India
Is Glycomet 500SR safe
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Very good question, you need to ask your doctor and a pharmacist where you get your mediation. We all react differently to medication.
We don't know the answer. May be doctor is best man to advise
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Dear Viswamitra
Please be updated that as of now there are 5 Indian pharma companies have recalled the Metformin ER/ SR from USA market - thanks to USFDA , in USA they have a very good system of reporting adverse effects and based upon that they act quickly to look in to the consumer complaints and take action. Apart from these 5 Indian pharma companies , there were some USA based pharma companies and pharma Companies from UK, Europe , Japan were also involved ....
So invariably there seems to be an issue of NDMA ( Nitrosodimethylamine) contamination during manufacturing process of Metformin SR/ ER ..which is a carcinogen . It may also create stomach bloating, pain and uneasiness...
The 5 Indian pharma companies who so far have recalled Metformin SR/ ER from USA market are :
1. Sun pharma
2 Lupin
3.Alkem
4.Marksons
5. Granules india
Glycomet made by USV is mainly sold in India..and supposed to be cheapest of all. And so USV is not able to cater to India market ...so much is the demand ...so perhaps they don't export to USA.
All pharma companies either get the API of Metformin ( active pharmaceutical ingredients) from China and if they get API from some indian API makers, the Indian API makers import the raw material from China.
Unfortunately in India there is no clear system of drug recall process . People don't report drug adverse reaction..
So , Glycomet SR can not be an exception.
If I were in your place , I would have consulted my doctor to switch from SR / ER to standard release form.
3 weeks back, perhaps you missed my post in DI... Please read this post below
Stay Safe Stay healthy !