Notice: Sandoz Recalls Ranitidine Hydrochloride Capsules

Date: 11/07/19

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

On October 28, 2019, the U.S. Food and Drug Administration (FDA) announced that Novitium Pharma LLC was recalling Ranitidine Capsules to the consumer level due to the products containing potential N-Nitrosodimethylamine (NDMA).

The FDA press release states the following:

Novitium Pharma LLC is recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the United States to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. To date, Novitium has not received any reports of adverse events related to use of the product as part of this recall. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. Ranitidine Hydrochloride Capsules are indicated for conditions where reduction of gastric secretion and acid output is desirable.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The identifying NDC numbers associated with Novitium’s recalled products are as follows: Ranitidine 150 mg capsules (NDC 70954-0001-20), Ranitidine 150 mg capsules (NDC 70954-0001-40), Ranitidine 300 mg capsules (NDC 70954-0002-10) and Ranitidine 300 mg capsules (NDC 70954-0002-40).

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