The U.S. Food and Drug Administration announced today that drug manufacturer Apotex is recalling its generic diabetes drug metformin after NDMA, a potential carcinogen, was discovered in a single lot of 500mg extended-release tablets.
Metformin is a popular medication that is often paired with diet and exercise to control type-2 diabetes mellitus in patients starting at age 10.
According to Drug Topics, however, Apotex stopped selling metformin in the United States in February 2019, and only limited product remains on the market.
Additional Metformin Recalls Already Requested
On the other hand, consumers should be aware that four additional as yet unnamed drug manufacturers have likewise been asked by the FDA to recall their own metformin products, according to The Wall Street Journal. At publication, no other metformin recalls had been announced.
The active ingredient metformin hydrochloride is sold under various brand names including Fortamet, Glucophage, Glumetza, and Riomet.
The FDA notified Apotex Pharmachem, Canada’s largest pharmaceutical company, in early May that the agency had found NDMA (N-nitrosodimethylamine) in excess of acceptable daily intake levels in a single lot. The FDA requested that Apotex recall the one tested lot.
However, according to the FDA statement, Apotex extended the recall to all remaining metformin hydrochloride lots in the United States “out of an abundance of caution.”
Advice for Affected Diabetes Patients
The metformin products which tested positive for excessive NDMA were 100-count bottles of 500mg extended-release metformin tablets with an NDC label number of 60505–0260–1. The NDC number can be found on the prescription bottle label or the packaging.
Patients who purchased bottles from this lot are advised by the FDA to call Inmar Rx Solutions at 1–888–985–9014 (option 1) (9 a.m. — 5 p.m., EST Monday through Friday) to arrange for the medication’s return.
Consumers with questions regarding the Apotex recall can contact the company by phone at 1–800–706–5575 (8:30 a.m. — 5 p.m., EST Monday through Friday) or by email at UScustomerservice@Apotex.com.
Concerned consumers are advised by the FDA to contact their physician or health care provider for medical guidance.
NDMA and Ranitidine
This is the second voluntary drug recall due to NDMA concerns in recent months. On April 1 the FDA requested an immediate voluntary recall of all over-the-counter and prescription ranitidine drug products due to concerns over NDMA contamination.
Ranitidine is the active ingredient in the popular heartburn medication Pepcid and its generic formulations.
The chemical NDMA has been classified by the International Agency for Research on Cancer of the World Health Organization as “probably carcinogenic” to humans. NDMA is an environmental contaminant which can be found in low levels in food and water.
There is strong evidence that NDMA is a “potent carcinogen” in experimental animals.
By MedTruth Editors