Greece's EOF drug safety authority has recalled two widely used stomach acid blockers on the recommendation of the European and American authorities after laboratory tests found them to contain the potentially dangerous chemical NDMA (N-Nitroso-dimethylamine).
EOF on Wednesday called for the withdrawal of 150 mg tablets of Zantac, distributed in Greece by GlaxoSmithKline, and 150 mg tablets of Ranitidine, from Generic Pharma Hellas.
In an announcement on Tuesday, Sandoz, the generics division of Swiss pahramaceutical firm Novartis, said in reference to American Food and Drug Administration guidelines that it is voluntarily recalling all lots of its 150 mg and 300 mg ranitidine hydrochloride capsules “because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.”
Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.