A sixth company has recalled its version of Type 2 diabetes drug Metformin Hydrochloride Extended Release Tablets 750 mg after finding some of the medicine contained too much of carcinogen NDMA.
Granules Pharmaceuticals’ company-written, FDA-posted recall notice says one lot tested as having N-Nitrosodimethylamine content that exceeded the FDA’s daily consumption limits. So the company took the precautionary step of recalling 12 lots of metformin.
In June, Apotex, Amneal, Teva and Marksans Pharma and Lupin recalled their metformin extended release tablets for the same reason after the FDA said it requested five companies do so. The FDA devoted a website page to information for metformin patients, but it hadn’t been updated with this recall as of Tuesday morning.
With these recalls and past recalls of blood pressure and heart medication for carcinogens such as NDMA and its cousins, the recommendation has been keep taking the medication until deciding on another treatment course with a doctor or pharmacist.
Granules pulled 11 lots of 100-count bottles, Nos. 4920003A, expiration date May-21; 4920004A and 4920005A, expiration date Jun-21; 4920009A, expiration date Nov-21; 4920010A, expiration date, May-22; 4920011A and 224920012A, expiration date Jun-22; 4920013A and 4920014A, expiration date Jul-22; 4920015A, expiration date Aug-22; and 4920016A, expiration date Jan-23.
The one lot of 500-count bottles recalled was lot No. 4920005B, expiration date Jun-21.
No other strengths of Granules’ Metformin Extended Release Tablets tablets are affected.
Inmar Pharmaceutical Services is handling questions and returns in this recall for Granules and can be reached at email@example.com or by phone at 888-985-9117, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
To report a health issue caused by this or any other drug, contact the FDA online or by phone at 800-332-1088.
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