Drug recall notice for nizatidine capsules

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of three lots of Mylan N.V. nizatidine capsules, opens new window on Jan. 8, 2020.1 We recommend you review your medical records and contact all patients for whom you have prescribed nizatidine to warn them of the recall. We have listed alternative options below.

Mylan voluntarily recalled three lots of nizatidine capsules (including 150 mg and 300 mg strengths). This recall was initiated because of potential contamination with N-Nitrosodimethylamine (NDMA) above levels established to be safe by the U.S. Food and Drug Administration (FDA). NDMA is classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). NDMA is a known environmental contaminant found in water and foods—including meats, dairy products and vegetables. To date, Mylan has not received any reports of adverse events related to use of the product as part of this recall.

This drug is an oral product used for the short-term treatment of active duodenal ulcers and benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

To stay up to date on the latest nizatidine recall information, monitor the FDA’s website, opens new window.

Recommendations:
Preferred formulary alternatives for Humana members:

Recalled medication Preferred alternative Mylan nizatidine capsules omeprazole capsules Mylan nizatidine capsules pantoprazole tablets Mylan nizatidine capsules cimetidine syrup Mylan nizatidine capsules famotidine syrup

Information for providers:1

  • We have sent a letter to your patients who have had a claim for nizatidine capsules and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • Patients with an existing inventory of Mylan recalled products can call Stericycle at 1-888-628-0727, from 8 a.m. to 5 p.m., Eastern time, to arrange for product return.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    • Online: Complete and submit the report .
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form .
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 1-800-FDA-0178.

Reference:

  1. “Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited.” U.S. Food and Drug Administration. Jan. 8, 2020. www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace, opens new window