- Mylan has started a voluntary nationwide recall on three lots of a commonly prescribed stomach ulcer drug after finding trace amounts of a probable human carcinogen, the drugmaker stated Wednesday.
- The recall is focused on three batches that were distributed in 2017 and 2018. Testing found low levels of NDMA, or N-nitrosodimethylamine, a likely carcinogen and environmental contaminant. Mylan said it had received no reports of related adverse events.
- The medicine, nizatidine, is approved as a short-term ulcer treatment as well as for the treatment of esophagitis and heartburn from gastroesophageal reflux disease, or GERD.
Mylan's limited recall is the latest instance of impurities in popular, generic medicines that have led to recalls after testing revealed unacceptable NDMA levels.
The Food and Drug Administration started investigating these NDMA impurities in 2018, initially focused on valsartan. That investigation has spread to include other -sartan medications and other antacids and heartburn drugs including ranitidine and nizatidine.
In a Jan. 8 statement, the FDA said it has asked manufacturers to conduct their own lab testing for NDMA and send samples to the FDA. The agency said it would recommend recalls for these drugs if their NDMA levels exceed 96 nanograms per day, the acceptable daily limit.
The FDA also alerted healthcare professionals and patients on Wednesday of voluntary recalls on ranitidine tablets by Appco Pharma and Northwind Pharmaceuticals.
In Mylan's case, the three recalled lots are for 150 mg and 300 mg capsules manufactured by Solara Active Pharma Sciences.
Despite the recall recommendations, the FDA has also said the estimated risk from the NDMA levels commonly seen in nizatidine and ranitidine are similar to levels found in common food like grilled or smoked meats.