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Ranitidine tablets sold at Rite Aid, Walmart and Walgreens recalled over cancer concerns

Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg sold at Walgreens, Walmart and Rite Aid over concerns the medications contain a probable carcinogen.

Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

To date, Apotex has not received any reports of adverse events related to use of the product.

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 Hydrochloride Tablet is an over the counter (OTC) oral product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. The affected Ranitidine Hydrochloride Tablets can be identified by NDC numbers stated on the product label.

The affected Ranitidine Hydrochloride Tablets were distributed Nationwide to Warehousing Chains. Apotex Corp.  has notified its affected direct account Warehousing Chains via mail by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, Distributors and Retailers return the impacted product to place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.  Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 800-967-5952 (option 1) (9:00 a.m. – 5:00 p.m., EST Monday thru Friday), to arrange for their return.

Consumers with questions regarding this recall can contact Apotex corp.  by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online.
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Jay Edwards

Born and raised in Northwest NJ, Jay has a degree in Communications and has had a life-long interest in local radio and various styles of music. Jay has held numerous jobs over the years such as stunt car driver, bartender, voice-over artist, traffic reporter (award winning), NY Yankee maintenance crewmember and peanut farm worker. His hobbies include mountain climbing, snowmobiling, cooking, performing stand-up comedy and he is an avid squirrel watcher. Jay has been a guest on America’s Morning Headquarters,program on The Weather Channel, and was interviewed by Sam Champion.

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