Monday, 20 January, 2020


More popular heartburn medications recalled due to impurity

RECALL Voluntary recall of Nizatidine ordered News RECALL Voluntary recall of Nizatidine ordered Recall Alert generic image
Patty Aguilar | 13 January, 2020, 18:23

Appco Pharma also recalled batches of ranitidine because of the potential presence of NDMA.

Since then, companies including Glenmark and Mylan have voluntarily recalled ranitidine and nizatidine medicines over concerns they may contain unacceptable levels of NDMA.

Mylan Pharmaceuticals is conducting a voluntary recall of three lots of Nizatidine Capsules, according to the U.S. Food & Drug Administration (FDA).

The recall is for unexpired products in two dosage amounts.

A known environmental contaminant found in water, and foods like meats, dairy products and vegetables, NDMA is classified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC). The investigation has been going on since 2018. Ranitidine is a drug found in Zantac and other heartburn medications. The 150 mg products are packaged in bottle packs containing units of 24, 30, and 90 tablets, whereas the 300 mg product is packaged in bottle packs containing units of 15 and 90 tablets.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Since then, several pharma companies including Hyderabad-based players like Dr Reddy's Laboratories and Aurobindo Pharma have initiated voluntary recall of Ranitidine from the U.S. market.

It can be unintentionally introduced into manufacturing through certain chemical reactions. However, the recall is due to impurities that could be cancer-causing.

Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

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