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Mylan recalls three lots of Nizatidine capsules

Trace amounts of N-Nitrosodimethylamine, a probable cancer have been found in the product

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Photo source: FDA
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:

NDCProduct DescriptionStrengthSizeLot NumberExpiry
0378-5150-91Nizatidine Capsules, USP150mgBottles of 603086746May 2020
0378-5300-93Nizatidine Capsules, USP300mgBottles of 303082876Jan 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.

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