Company Announcement Date: September 25, 2019
FDA Publish Date: September 25, 2019
Product Type: Drugs
Reason for Announcement: Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)
Company Name: Apotex Corp.
Brand Name: Apotex Corp.
Product Description: Ranitidine Tablets 75mg and 150mg
Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. 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.
Risk Statement: 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 (FedEx Standard Overnight) 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) (9:00am – 5:00-pm, 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.