More popular heartburn medications recalled due to impurity

Henrietta Strickland
January 12, 2020

In addition, Appco Pharma LLC recalled 150 mg and 300 mg batches of its ranitidine hydrochloride capsules. However, the recall is due to impurities that could be cancer-causing.

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. For example, according to CNN, "Last year, drugmaker Novartis said it would stop distribution of all ranitidine medicines made by Sandoz; Dr. Reddy's Laboratories Ltd. recalled its ranitidine medicines; and Sanofi recalled Zantac OTC, its popular heartburn medication". The recalled lots have an expiration date of April or May 2021.

Neither company reported any adverse events directly related to the recall, but nevertheless advised consumers to immediately discontinue use, discard the product and consult physician for other treatment options.

On Wednesday, the FDA also announced that the drug company Mylan has recalled three lots of another antacid, nizatidine, which were also found to contain trace amounts of NDMA. Trace amounts of NDMA were found in the drug, which was manufactured by Solara Active Pharma Sciences Limited.

FDA said Nizatidine is used to treat ulcers, gastroesophageal reflux disease and conditions that cause too much stomach acid.

The recalled medications include 60-count bottles of 150mg Nizatidine Capsules, USP expiring in May of 2020 with lot number 3086746; 30-count bottles of 300mg Nizatidine Capsules, USP expiring in January of 2020 with lot number 3082876; and 30-count bottles of 300mg Nizatidine Capsules, USP expiring in January of 2020 with lot number 3082877, according to Mylan.

The FDA said it has not received any reports of injuries associated with taking the medications. FDA testing of recalled ranitidine detected NDMA levels similar to the levels found in grilled and smoked meats.

Other reports by Click Lancashire

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