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Appco Pharma LLC Recalls Ranitidine Capsules

Date: 01/14/20

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On January 8, 2020, the U.S. Food and Drug Administration (FDA) announced that Appco Pharma LLC was recalling Ranitidine Capsules to the consumer level due to the products containing N-Nitrosodimethylamine (NDMA).

The FDA press release states the following:

Appco Pharma LLC is voluntary recalling all lots of Ranitidine Capsules (150 mg, 300 mg) due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA, based on FDA-validated tests. 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. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The NDC numbers associated with Appco’s recalled products are as follows: Ranitidine 150 mg capsules (NDC 62559-0690-05, 62559-0690-60) and Ranitidine 300 mg capsules (NDC 62559-0691-30).

Providers can review the FDA’s full press release here.