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OTC Heartburn Medication Recalled


December 13, 2019

Sanofi-Aventis US issued a precautionary, voluntarily recall of all over-the-counter Zantac (ranitidine) products because of possible contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen. The recalls were listed in the December 11, 2019, US Food and Drug Administration (FDA) Enforcement Report.

“On September 13, 2019, the FDA issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing,” Sanofi explained in an October 23, 2019, press release. “Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the US products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues.” 

All lots of the following products, distributed throughout the United States by Chattem Inc., a Sanofi Company, were included on the FDA’s most recent recall list:

  • Zantac, 75 mg (NDC 0597-0122-01, NDC 0597-0122-08, NDC 0597-0122-13, NDC 0597-0122-37, NDC 0597-0122-40, NDC 0597-0122-54, NDC 0597-0122-61, NDC 0597-0122-81, and NDC 0597-0122-96);
  • Zantac, 150 mg (NDC 66715-9736-2, NDC 66715-9736-3, and NDC 66715-9736-8);
  • Regular Strength Zantac, 75 mg (NDC 41167-0300-0, NDC 41167-0300-1, NDC 41167-0300-3, NDC 41167-0300-5, NDC 41167-0300-6, NDC 41167-0300-7, NDC 41167-0300-8, NDC 50269-222-25, NDC 67751-152-01, NDC 67751-152-02, and NDC 68151-2584-0);
  • Regular Strength Zantac, 150 mg (NDC 05269-220-25 and NDC 67751-151-01); and
  • Maximum Strength Zantac, 150 mg (NDC 0597-0121-01, NDC 0597-0121-06, NDC 0597-0121-08, NDC 0597-0121-09, NDC 0597-0121-11, NDC 0597-0121-24, NDC 0597-0121-38, NDC 0597-0121-50, NDC 0597-0121-64, NDC 0597-0121-66, NDC 0597-0121-68, NDC 0597-0121-78, NDC 0597-0121-80, NDC 0597-0121-82, NDC 0597-0121-85, NDC 0597-0121-90, NDC 0597-0121-94, NDC 41167-0310-1, NDC 41167-0310-2, NDC 41167-0310-3, NDC 41167-0310-4, NDC 41167-0310-6, NDC 41167-0310-7, and NDC 41167-0310-8). 

The recalls were initiated by Sanofi-Aventis on October 22, 2019. On December 1, 2019, the FDA designated them Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Over-the-counter ranitidine is used to prevent and relieve heartburn associated with acid ingestion and sour stomach.

Jolynn Tumolo

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