January 8, 2020
Several products used to treat gastrointestinal (GI) conditions have been voluntarily recalled due to the presence or potential presence of N-nitrosodimethylamine (NDMA). NDMA is a known environmental contaminant found in food and water and is considered a probable human carcinogen (a substance that may cause cancer).
The following manufacturers have issued voluntary recalls of their products:
- Mylan Pharmaceuticals, Nizatidine Capsules 150mg and 300mg belonging to lot numbers 3086746, 3082876, and 3082877.
- Appco Pharma, Ranitidine Hydrochloride Capsules 150mg and 300mg, all lots within expiry.
- Northwind Pharmaceuticals, Ranitidine Tablets 150mg and 300mg, all lots within expiry.
At the time of the recalls, none of the manufacturers had received reports of adverse events related to the products.
Both Appco Pharma and Northwind Pharmaceuticals have advised consumers to immediately discontinue use of the recalled products and ask their healthcare provider about treatment options. Patients who may have experienced an adverse event related to the use of any of the recalled products listed above should speak to their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
Specific instructions regarding returns as well as other recall details can be found at the FDA’s website:
- Mylan – Nizatidine Capsules
- Appco Pharma – Ranitidine Hydrochloride Capsules
- Northwind Pharmaceuticals – Ranitidine Tablets
Benecard Central Fill did not distribute any of the recalled products.