Mylan Pharmaceuticals has issued a recall of three lots of a medication used to treat acid reflux disease because trace amounts of a carcinogen were detected.
Nizatidine capsules in 150 mg and 300 mg strengths are being recalled. They were manufactured by Solara Active Pharma Sciences Limited and distributed between June 2017 and August 2018.
The recall includes:
- NDC No. 0378-5150-91, nizatidine capsules, 150 mg, bottles of 60, Lot No. 3086746, expires May 2020
- NDC No. 0378-5300-93, nizatidine capsules, 300 mg, bottles of 30, Lot No. 3082876, expires January 2020
- NDC No. 0378-5300-93, nizatidine capsules, 300 mg, bottles of 30, Lot No. 3082877, expires January 2020
According to an announcement with the U.S. Food and Drug Administration, trace amounts of N-nitrosodimethylamine (NDMA) were found in the drug.
“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).”
The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor.
Nizatidine is used for the short-term treatment of ulcers, esophagitis and associated heartburn due to gastroesophageal reflux disease.
To return the medications, contact Stericycle at 888-628-0727, 8 a.m. to 5 p.m. weekdays.
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