Mylan Pharmaceuticals Inc. is recalling certain batches of its Nizatidine Capsules, USP, over concerns they may contain a carcinogen.
Mylan Pharmaceuticals Inc. recently issued a nationwide voluntary recall for three lots of Nizatidine Capsules, USP, including the 150mg and 300mg strengths. The antacid capsules were recalled after the company discovered trace amounts of an impurity N-nitrosodimethylamine (NDMA) in the API Nizatidine, USP. Fortunately, the company hasn’t received reports of consumers experiencing adverse reactions from taking the recalled products.
NDMA is particularly dangerous because the International Agency for Research on Cancer (IARC) has classified it as a probable human carcinogen, meaning it could cause cancer. Unfortunately, NDMA “is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables.”
According to the recall notice, the finished products were manufactured by Mylan Pharmaceuticals Inc. and were distributed nationwide to “wholesalers, mail-order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.” The specific batches affected by the recall include:
| 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
|
At the moment, Mylan is sending letters to its customers and distributors with information about the recalled products. Anyone who has the recalled products should contact Stericycle at 888-628-0727 to dispose of the products. If you or someone you know consumed one of the products and may be experiencing health problems as a result, contact a healthcare provider immediately.
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