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Perrigo Recalls Ranitidine Due To Possible Presence Of NDMA

Perrigo Company plc (PRGO) Wednesday said it has initiated a voluntary, worldwide product recall of ranitidine, due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine.

NDMA is classified as a probable human carcinogen, a substance that could cause cancer, based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is an over-the-counter and prescription product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On October 8, 2019, Perrigo halted shipments of the product based upon preliminary results.

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