Heartburn medicine recalled: Ranitidine mediciations might contain impurity

13 Janvier, 2020, 18:18 | Auteur: Yves Courtet
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The Food and Drug Administration said Denton Pharma Inc. and Appco Pharma have both recalled batches of Ranitidine tablets due to the possible presence of NDMA.

Denton Pharma Inc. this week recalled several batches of ranitidine tablets. The FDA has been investigating NDMA since 2018. The recall impacts all unexpired lots of 150 mg and 300 mg tablets. Ranitidine Capsules 150 mg and Ranitidine Capsules 300 mg were distributed nationwide.

Consumers who have the recalled products should immediately discontinue use, discard the remaining products and consult with a health care provider about treatment options. USFDA had advised companies to recall their Ranitidine products if testing showed levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million).

Ranitidine, known by the brand name Zantac, is a histamine-2 blocker that decreases the amount of acid in the stomach to treat and prevent stomach ulcers and gastroesophageal reflux disease also known as GERD.

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It can be unintentionally introduced into manufacturing through certain chemical reactions.

Pharmacies have pulled generic versions of heartburn drug Zantac from shelves after federal officials disclosed two voluntary recalls this week over NDMA, a probable human carcinogen in the drug.

The FDA released the results of preliminary tests of safer, carcinogen-free antacid alternatives, including the likes of Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole), all of which were found to have no traces of the potentially cancer-causing agent NDMA.

According to FDA, Mylan has not received any reports of adverse events related to these batches.

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