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Discussion Starter · #1 ·
The FDA is telling five drugmakers to recall versions of metformin after laboratory tests found elevated levels of N-Nitrosodimethylamine, the chemical that was found in dozens of shipments of blood pressure and heartburn drugs last year, triggering recalls of those medications.

Of course, keep taking these versions of metformin if you have them; going without it is a much higher health risk than the presence of the contaminant. But it might be good to know that some supplies may be recalled. The linked article has more details.
 

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Something like that could drive me crazy. The FDA lists only one of the manufacturers, Apotex, and not the other 4 they've recalled. I am on ER Metformin, NOT by Apotex, but how am I supposed to know whether mine is one of the four others (mine isn't made by Apotex)??
 

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Discussion Starter · #3 ·
how am I supposed to know whether mine is one of the four others??
Fair question. They have not yet been named.

Apparently the main issue is that it is uncertain which brands or specific lots of medication are subject to recall:

FDA laboratories tested the same metformin lots [as] the private laboratory [...] The agency confirmed unacceptable NDMA levels in some, but not all, of those lots. In other instances, [the agency's] laboratory detected NDMA in lots that the private laboratory did not.
Personally, I think they would have been better off not quantifying other manufacturers if they were not ready to name them. But, from the manufacturer's perspective, if their product passes (which, according to similar tests, it does), they don't need to do an expensive recall.

Doesn't make it easier if you're taking a metformin product that’s not by Apotex.
 

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Fair question. They have not yet been named.

Apparently the main issue is that it is uncertain which brands or specific lots of medication are subject to recall:



Personally, I think they would have been better off not quantifying other manufacturers if they were not ready to name them. But, from the manufacturer's perspective, if their product passes (which, according to similar tests, it does), they don't need to do an expensive recall.

Doesn't make it easier if you're taking a metformin product that’s not by Apotex.
Guess I'll have to switch to short acting Metformin, grrrr.
 

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Discussion Starter · #5 ·
Guess I'll have to switch to short acting Metformin, grrrr.
Not necessarily, Tracker. Several companies make extended-release metformin. Of course, without knowing which brands are involved, it's hard to ask to switch to another brand without knowing if you are leaping out of the figurative frying pan into the figurative fire. The fact that the values are ambiguous is even a bit encouraging -- they apparently are so low that there is a question of what level may be harmful.

Of course, the damage a diabetic can experience by not taking their metformin is much more immediate and known than these low levels of N-Nitrosodimethylamine. I'm not saying there's no issue here -- I'm not qualified to state that -- but I would think twice before I messed with something that was working for you. It may be that your current brand of met is fine and absolutely no change is necessary. It's a matter of waiting to see. I'll be monitoring what I see about this topic.
 

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Discussion Starter · #7 ·
I didn't realize it at the time, but forum member rsfletcher posted on this subject about a similar recall in Canada back in March. As a mod, I'm sure I saw his post, but it didn't register for me that this was the same topic (but in the U.S.) when I posted.

Anyway, the FDA has released the names of the manufacturers which will be urged to recall their extended-release metformin. I will update the other thread with the same chart.
 

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Discussion Starter · #9 ·
Well, almost five months later and some bottles of another brand of metformin are being recalled. Nostrum Laboratories is recalling four lots of metformin:

100-tablet bottles of 750 mg Metformin Hydrochloride Extended Release Tablets, lot Nos. MET200101 and MET200301; and 500 mg Metformin Hydrochloride Extended Release Tablets, lot Nos. MET100201 and MET100401. All recalled bottles have an expiration date of 05/2022.
 

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Discussion Starter · #10 ·
Nostrum Laboratories is recalling four lots of metformin
Make that five lots. Metformin HCl Extended Release Tablets, USP 750 mg, lot #MET200501, expiration 07/2022.
 

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Discussion Starter · #12 ·
Adding another lot of Nostrum Laboratories' metformin to the recall list:

Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 750 mg
NDC number 29033-056-01
Lot number MET200601
Expiration date 07/2022
 

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Just bumping this thread. Is anyone taking Metformin ER made by Ascend? Their website says the drug is contaminate free but other sites say it tested positive for NMDA.
 

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Just bumping this thread. Is anyone taking Metformin ER made by Ascend? Their website says the drug is contaminate free but other sites say it tested positive for NMDA.
JagTac, I don't know which other sites may be stating positive results for Ascend's metformin. The FDA recalls Web site shows that they have tested Ascend brands of metformin, but did not find any NMDA in their samples:

12602


A Web search I just ran for ascend metformin er nmda recall did not return any results for Ascend's products, either. May I ask where you saw the announcement you're referring to?
 

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JagTac, I don't know which other sites may be stating positive results for Ascend's metformin. The FDA recalls Web site shows that they have tested Ascend brands of metformin, but did not find any NMDA in their samples:

View attachment 12602

A Web search I just ran for ascend metformin er nmda recall did not return any results for Ascend's products, either. May I ask where you saw the announcement you're referring to?

I believe it was a third party lab. I don’t remember the actual name or where I saw that. The confusion of course is that both the FDA and Ascend state that their metformin is safe. It has been a while and I continue to take the drug myself.

I was checking to see what others may have seen or come up with.
 

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Discussion Starter · #16 ·
I'll keep looking, JagTac; I have an alert set on the FDA Web site for when they update it. It's important to know if there's anything but met in the tablets. But so far it appears to be clean.
 

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Discussion Starter · #17 ·
Adding a new manufacturer: Viona Pharmaceuticals, recalling specific batches of 750mg Metformin extended release tablets with an expiration date of October 2021. Here's the official USDA recall notice.
 

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My pharmacy just switched brands on me from Ascend to Granules. Never heard of Granules. HQ in India from searching on the web.
 
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