The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. This medication is being recalled due to low levels of a nitrosamine impurity. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
Why is it being recalled?
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.
What products are recalled?
The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots. The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.
FDA is not recommending individuals stop taking all ranitidine medicines at this time.
Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742