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You need to know about an expanded recall on a drug that could contain a dangerous substance.
If you’re among the large group of Americans who takes a daily medication, you’re going to want to know about an expanded recall the U.S. Food & Drug Administration (FDA) just announced. It has been found that a common drug on the market right now contains too much of a carcinogen. Read on to find out what and why the tablets are being recalled, plus what to do if you require this medicine for your health.
RELATED: If You Use This Medication, Stop Immediately, FDA Says.
Cranford, New Jersey-based Viona Pharmaceuticals is voluntarily recalling 23 lots of the 750-milligram Metformin hydrochloride extended-release tablets at the consumer level, according to the FDA.
The latest recall, published Jan. 12, 2022, comes after the company voluntarily recalled 33 different lots back in December.
The reason for the recall is that the drugs could contain too much N-nitrosodimethylamine (NDMA), which is “classified as a probable human carcinogen,” that could cause cancer based on results from laboratory tests.
As a precautionary measure, the company is voluntarily recalling all the potentially affected batches with a valid shelf life. The drugs are manufactured by Cadila Healthcare Limited in Ahmedabad, India for distribution in the U.S.
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Many people with type 2 diabetes can control their disease with diet and exercise, and Metformin is a drug that can help in combination with these two lifestyle changes. It is used to treat high blood sugar levels resulting from the disease by not only lowering blood sugar but helping “restore the way you use food to make energy,” says the Mayo Clinic.
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If you take this drug, find your medicine bottle and check the lot number against the 23 new lots listed along with the recall notice on the FDA website.
The tablets are packaged in bottles of 100 and were distributed to retailers around the country. Each is white to off-white in color, capsule-shaped, and uncoated, debossed with “Z” and “C” on one side, and “20” on the other side.
If you have drugs from an impacted lot, stopping taking them cold turkey could be dangerous to your health. Instead, keep taking your medication and contact your doctor for advice on next steps.
Fortunately, there haven’t been any reports of adverse events related to the recall at this time.
Viona Pharmaceuticals is currently notifying its customers of the recall by email and mail. It is arranging for the return of all recalled medications to its recall processor at the following address:
Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050
If you have questions, contact recall processor Inmar Pharmaceutical Services by phone at 855-249-3303 (option 1) Monday through Friday (excluding holidays) from 9:00 am to 5:00 pm EST. Contact your doctor if you have experienced any health problems that may be related to the recalled drug.
If you want to report an adverse health issue, or quality issues about the recalled products, call Viona Pharmaceuticals at 888-304-5011, Monday through Friday from 8:30 am to 5:30 pm EST.
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