FDA NewsPerspective

Sandoz voluntarily recalls generic forms of Zantac

Ned Sharpless

Sandoz has voluntarily recalled all generic forms of Zantac (ranitidine) in the United States after noting confirmed contamination with N-Nitrosodimethylamine (NDMA), a possible human carcinogen, above established FDA levels, according to a company press release

Sandoz noted that it has not received reports of any adverse events related to use of the medications as part of the recall.

The recall comes approximately one week after the manufacturer halted distribution of the medication.

The recall includes ranitidine hydrochloride capsules at 150 mg and 300 mg doses sold in 30, 60 and 500 count bottles.

  • For a full list of recalled medications, click here.

For more on how various gastroenterologists are handling the recall, click here.

As a part of the recall, wholesalers are asked to stop distribution immediately and return any stock to Sandoz. Pharmacies are being asked to immediately stop dispensing the medications and return any remaining stock to Sandoz by contacting Stericycle to request a recall packet. People receiving the medications, according to the manufacturer release, should continue taking their medication and speak to their physician or pharmacist about alternative treatment options.

Acting FDA Commissioner Ned Sharpless, MD, noted that the FDA is committed to ensuring that medications distributed to Americans are safe and effective.

“We began testing ranitidine products immediately after we learned of the potential impurity,” Sharpless said in an FDA-issued press release. “When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”

The FDA noted that patients can still take the forms of ranitidine that have not been recalled as the agency continues to investigate the risks.

“We are continuing our investigation along with our international counterparts, and we will keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.

Editor’s note: Apotex Corp. on September 25 announced it was voluntarily recalling all pack sizes and formats of ranitidine 75 mg and 150 mg, and labeled by Walgreens, Walmart and Rite-Aid.

Ned Sharpless

Sandoz has voluntarily recalled all generic forms of Zantac (ranitidine) in the United States after noting confirmed contamination with N-Nitrosodimethylamine (NDMA), a possible human carcinogen, above established FDA levels, according to a company press release

Sandoz noted that it has not received reports of any adverse events related to use of the medications as part of the recall.

The recall comes approximately one week after the manufacturer halted distribution of the medication.

The recall includes ranitidine hydrochloride capsules at 150 mg and 300 mg doses sold in 30, 60 and 500 count bottles.

  • For a full list of recalled medications, click here.

For more on how various gastroenterologists are handling the recall, click here.

As a part of the recall, wholesalers are asked to stop distribution immediately and return any stock to Sandoz. Pharmacies are being asked to immediately stop dispensing the medications and return any remaining stock to Sandoz by contacting Stericycle to request a recall packet. People receiving the medications, according to the manufacturer release, should continue taking their medication and speak to their physician or pharmacist about alternative treatment options.

Acting FDA Commissioner Ned Sharpless, MD, noted that the FDA is committed to ensuring that medications distributed to Americans are safe and effective.

“We began testing ranitidine products immediately after we learned of the potential impurity,” Sharpless said in an FDA-issued press release. “When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern.”

The FDA noted that patients can still take the forms of ranitidine that have not been recalled as the agency continues to investigate the risks.

“We are continuing our investigation along with our international counterparts, and we will keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.

Editor’s note: Apotex Corp. on September 25 announced it was voluntarily recalling all pack sizes and formats of ranitidine 75 mg and 150 mg, and labeled by Walgreens, Walmart and Rite-Aid.

    Perspective
    Ronnie Fass

    Ronnie Fass

    Several companies, including Apotex, Novartis-owned Sandoz and GlaxoSmithKline, voluntarily recalled ranitidine products in the U.S. and other parts of the world. It appears that Zantac-related drugs contain a high level of NMDA, a known carcinogen. Thus far, the only H2 blocker being affected is Zantac, leaving the other compounds from the same class of drugs available for patients’ use. Overall, there is very little difference in clinical efficacy among the different H2 blockers, and thus they are likely to fill in for Zantac, until the NMDA contamination issue is resolved. The safety profile of the other H2 blockers is similar except cimetidine, which can be associated with gynecomastia in patients who are receiving the drug for more than 1 month.

    • Ronnie Fass, MD
    • Professor of Medicine,
      Case Western Reserve University
      Medical Director, Digestive Health Center
      Head, Esophageal and Swallowing Center,
      MetroHealth Medical Center

    Disclosures: Fass reports no relevant financial disclosures.