Drug Safety Alerts

Appco Ranitidine Capsules Consumer-Level Recall

1/7/2020

On January 7, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of all unexpired lots of Ranitidine 150 mg and 300 mg capsules manufactured by Appco. This recall was issued because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. Appco has stated that as of the date of its announcement, it has not received any reports of adverse events that have been confirmed to be directly related to this recall.

A list of the recalled products and unexpired lot numbers affected by this recall is provided here:

Risk Statement: NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

Consumers with questions regarding this recall can contact Appco at: (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: pv@appcopharma.com or at ANI Pharmaceuticals, Inc. at 1-800-308-6755 or PVSupport@safetycall.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers who have Ranitidine capsules, USP subject to this recall should stop using and consult with their physician or healthcare provider about treatment options.

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:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please contact Appco at (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail pv@appcopharma.com. Consumers may also contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or PVSupport@safetycall.com. You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.