2020's metformin recalls have bled into the new year. Just this week, Nostrum Laboratories, which already extended a product pull earlier this month, put another lot on the chopping block thanks to familiar contamination fears.
Monday, Nostrum said it had recalled another lot of its 750-mg extended release metformin tablets due, once again, to higher-than-allowed levels of the possible carcinogen N-nitrosodimethylamine (NDMA). The move extends a metformin recall Nostrum issued in November, which the company first expanded in early January when it yanked another single lot of the popular diabetes med.
The suspect lot, at the same metformin dosage covered in Nostrum's previous pulls, was set to expire in July of 2022. It's unclear how many 100-tablet-count bottles are contained in each lot, and a Nostrum spokesperson wasn't immediately available for comment.
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As of the latest recall announcement, Nostrum hadn't received any side effect reports. The company is asking distributors to return the potentially tainted product and has urged patients to seek a replacement drug or an alternative treatment.
Monday's metformin recall isn't Nostrum's first this year. The Missouri-based company on Jan. 5 yanked a single lot of 750-mg extended release metformin after higher-than-normal NDMA levels turned up in samples.
That product withdrawal was itself an extension of Nostrum's initial voluntary recall in November, which saw the company pull two 750-mg metformin lots over the same contamination fears.
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Metformin's carcinogen woes kicked off in May of last year when the FDA identified NDMA in the widely used drug. Following that discovery, the regulator pressed five companies—Apotex, Actavis, Amneal, Lupin and Marksans—to pull their extended release metformin products.
Turns out, that was just the tip of the iceberg. In July, Lupin pulled all remaining lots of its extended release metformin while Marksans, which originally withdrew one lot of 500-mg pills, yanked another 76 lots in October.
Bayshore Pharmaceuticals, based out of New Jersey, pulled one lot each of its 500- and 750-mg extended-release metformin in August. And Sun Pharma in September recalled one lot of its metformin product Riomet ER, which covered 747 bottles of the drug.