Drug Safety Alerts

Nizatidine Capsules Manufactured by Mylan Consumer-Level Recall

1/8/2020

On January 8, 2020, the United States Food and Drug Administration (FDA) published a notice about a consumer-level recall of Nizatidine 150 mg and 300 mg capsules manufactured by Mylan Pharmaceuticals. This recall was issued due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A list of the affected products and list numbers is provided here:

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).

The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Nizatidine 150 mg and/or 300 mg capsules to contact their prescriber.

For more information about this recall, please contact Mylan Pharmaceuticals toll-free at 1-800-796-9526 or visit https://newsroom.mylan.com.You may also contact the FDA at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.