Drug Safety Alerts

Nizatidine Oral Solution Consumer-Level Recall

4/15/2020

On April 15, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) 480 mL bottles NDC # 60846-0301-15 manufactured by Amneal Pharmaceuticals. This recall was issued due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. This recall affects lot numbers 06598004A exp. 04/2020, 06599001A exp. 12/2020 and 06599002A exp. 12/2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

According to Amneal, it has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Amneal has advised that consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 1-855-319-4807, Monday through Friday, 8:00 am to 5:00 pm (ET) for further information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) to contact their prescriber.

For more information, health care providers may contact Amneal Drug Safety at 1-877-835-5472, Monday through Friday, 8:00 am to 6:00 pm (ET) or visit https://investors.amneal.com.

You may also contact the United States Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.