- Apotex Corp is voluntarily recalling over-the-counter (OTC) ranitidine distributed to Rite Aid, Walgreens, and Walmart stores nationwide.
- The recall is precautionary, in response to reports that some ranitidine products are contaminated with N-nitrosodimethylamine (NDMA), a probable carcinogen.
- Affected products include 75-mg and 150-mg tablets, identifiable by the NDC numbers on product labels.
What patients and providers should do
- Patients should talk with health care providers about problems possibly related to taking these products.
- Patients and providers should report any adverse reactions to the FDA’s MedWatch program.
- Patients and providers can call Apotex at 1-800-706-5575 from 8:30 a.m. to 5 p.m. EST Monday through Friday, or send an email to [email protected] for more information.
What retailers, distributors, and wholesalers should do
- Retailers, distributors, and wholesalers should quarantine recalled products immediately and return them to their suppliers.
- Those who purchased products directly from Apotex should call Inmar Rx Solutions at 800-967-5952 (option 1) from 9 a.m. to 5 p.m. Monday through Friday to return them.
What the FDA is doing
- The FDA continues testing ranitidine products and assessing possible effects on patients, as well as ways manufacturers can reduce or eliminate contamination.
- The agency will provide more information as it becomes available.