Mylan Pharmaceuticals is recalling three lots of Nizatidine capsules.
Trace amounts of N-Nitrosodimethylamine, a probable cancer causer, have been found in the product, which is used for treatment of ulcers.
There are no reports of adverse reactions to date.
The following batches of the product, distributed nationwide to wholesalers, mail order pharmacies and retail pharmacies, between June 2017 and August 2018 are being recalled:
|NDC||Product Description||Strength||Size||Lot Number||Expiry|
|0378-5150-91||Nizatidine Capsules, USP||150mg||Bottles of 60||3086746||May 2020|
|0378-5300-93||Nizatidine Capsules, USP||300mg||Bottles of 30||3082876||Jan 2020|
|0378-5300-93||Nizatidine Capsules, USP||300mg||Bottles of 30||3082877||Jan 2020|
What to do
Patients who are in possession of the recalled product should contact Stericycle at (888) 628-0727 Monday through Friday, 8 a.m. to 5 p.m. (EST) for return of the recalled product.