Drug Safety Alerts

AvKARE Amneal Ranitidine Recall

11/14/2019

On November 14, 2019, AvKARE issued a consumer-level recall of Ranitidine 150 mg tablets and Ranitidine 300 mg tablets manufactured by Amneal and distributed by AvKARE. This recall was issued because of potential N-nitrosodimethylamine (NDMA) amounts above levels established by the United States Food and Drug Administration (FDA).

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 is provided here.

Health Hazard Assessment: 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall please contact AvKare at 1‑855‑361‑3993 or visit www.avkare.com. You may also contact the FDA 1‑888‑INFO-FDA (1‑888‑463-

332) or visit www.fda.gov.