FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Ranitidine Tests Find NDMA Levels Akin to Levels in Food, Woodcock Says

Nov. 13, 2019

The latest results from the FDA’s testing of ranitidine products for N-Nitrosodimethylamine (NDMA) contamination showed NDMA levels similar to those found in common foods like grilled or smoked meats, according to CDER Director Janet Woodcock.

The agency posted a summary of its findings online. Novitium’s prescription ranitidine 300 mg topped the NDMA levels with 2.85 ppm. Aurobindos’ ranitidine 300 mg was next at 1.86 ppm.

The agency has also asked manufacturers to voluntarily recall another H2 blocker nizatidine, or Axid, if they find NDMA above the acceptable daily intake level because it is chemically similar to ranitidine.

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