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itissteve 05-29-2020 22:47

Some metformin being recalled
 
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.

Tracker 06-01-2020 19:36

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)??

itissteve 06-01-2020 20:27

Quote:

Originally Posted by Tracker (Post 1326527)
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:

Quote:

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 thatís not by Apotex.

Tracker 06-02-2020 01:09

Quote:

Originally Posted by itissteve (Post 1326531)
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 thatís not by Apotex.

Guess I'll have to switch to short acting Metformin, grrrr.

itissteve 06-02-2020 01:31

Quote:

Originally Posted by Tracker (Post 1326533)
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.

Tracker 06-02-2020 01:48

Sounds good, itissteve, thanks!

itissteve 06-08-2020 15:00

1 Attachment(s)
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.

itissteve 06-12-2020 15:12

Looks like Lupin Pharmaceuticals is recalling ER met as well.

itissteve 11-04-2020 14:28

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.

itissteve 01-05-2021 04:40

Quote:

Originally Posted by itissteve (Post 1328051)
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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