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As concerns about problems with contamination of the heartburn drug Zantac continue to mount, another generic drug maker has recalled their version of the ranitidine-based medication due to the presence of potentially cancer-causing chemical impurities.
Apotex Corp. announced a generic ranitidine recall at the retail level on September 25, which removes the over-the-counter pills from pharmacy store shelves. However, the manufacturer is not calling for consumers to return versions of the generic Zantac they already purchased, or dispose of pills that remain in homes nationwide.
The action follows a string of Zantac recalls and announcements that different manufacturers are ceasing distribution of the widely used medication, following the FDA’s September 13 warning that certain versions of Zantac contain high amounts of N-nitrosodimethylamine (NDMA).
The heartburn drug contaminant may be a byproduct of the manufacturing process, and is a probable human carcinogen, which may increase the risk of liver cancer, stomach cancer, colorectal cancer, and other digestive tract cancers.
NDMA contamination has been a focus for federal health officials, after the presence of the chemical led to massive valsartan recalls last year, impacting most of the U.S. supply for that blood pressure drug. Investigations have since revealed that changes to the manufacturing process for generic versions of valsartan may have caused the contamination, and hundreds of individuals are now pursuing lawsuits indicating that they developed cancer after long-term exposure to the hypertension drug.
It now appears that all forms of Zantac were contaminated with large amounts of NDMA, and early investigations suggest that the chemical may have been in the heartburn drug since it was first introduced, potentially exposing millions of users to an increased risk of cancer due to long-term exposure.
According to the FDA statement issued earlier this month, NDMA levels were detected by the online pharmacy Valisure, which found that some Zantac pills contained more than 26,000 times the amount of NDMA that the FDA deems safe to consume in one day.
This latest recall affects all pack sizes and formats of Ranitidine Tablets sold in 75mg and 150mg strength sold under the Rite Aid, Walmart and Walgreen’s labels. The Walgreen’s version is sold under the name Wal-Zan. A complete list of the pack sizes’ and NDC Numbers is available on the recall notice.
The affected tablets were distributed nationwide by Apotex Corp.
The manufacturer is recommending wholesalers, distributors and retailers return recalled tablets to the place of purchase. Those with existing inventory should quarantine the recalled lots immediately. Customers who purchased recalled ranitidine tablets directly from Apotex can call Inmar Rx Solutions at 800-967-5952 and select Option 1 to arrange to return them.
Consumers with questions can call Apotex Corp. at 1-800-706-5575 or be sending an email to UScustomerservice@apotex.com. Adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
For individuals diagnosed with cancer, lawyers are now evaluating whether Zantac recall lawsuits may provide compensation as a result of the drug makers’ failure to warn about the presence of the cancer-causing impurity.