Rite Aid, Walgreens, and Walmart supplier issues ranitidine recall

  • US Food and Drug Administration
  • 25.09.2019

  • von Craig Hicks
  • Clinical Essentials
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Takeaway

  • 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 UScustomerservice@apotex.com 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.