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Zantac Generics Recall Grows Due to Cancer Risk



Additional generic editions of Zantac are being taken down from pharmacy shelves after officials detected low levels of a possible carcinogen in the heartburn medication.

Hepatotoxic Chemical Discovered

The Food and Drug Administration announced further recalls of ranitidine medicines that subdue stomach acid and ulcers this week. The skepticism over a possible cancer risk comes from the presence of a potential carcinogen named NDMA (Nitrosodimethylamine) which has also prompted the recall of various editions of blood pressure-lowering pills.

A cycle of recalls have been carried out in the past few months. Drugstore chains CVS and Walgreens have discontinued selling Zantac and numerous generic versions.

In the recent batch declared this week, Denton Pharma and Appco Pharma granted spontaneous recalls.

Reactions of Pharmaceuticals Makers

Denton, which is in business as Northwind Pharmaceuticals, announced that it is recalling every 150-milligram and 300-milligram Ranitidine Tablets. However, the company declared it had not approved any reports of similar “adverse events,” more commonly known as ailments, injuries or deaths. Nonetheless, it advised consumers to instantly withdraw from use and discard the medicine.

Individually, Appco granted a voluntary recall for all of its 150-milligram and 300-milligram Ranitidine Hydrochloride Capsules. The company said it is unaware of any adverse events linked to the prescription drug but advised dependents to forgo taking it and go to physicians to advise them on possible alternative treatments.

Another pharmaceutical maker, Mylan, granted a voluntary recall for all of its 150-milligram and 300-milligram versions of ulcer and heartburn treatment Nizatidine Capsules after discovering “trace amounts” of NDMA in the medication, which is produced by Solara Active Pharma Sciences Limited.

Emery Pharma, an Alameda, California-based private lab, directed an analysis on the stability of ranitidine and found the medication seems to generate NDMA when exposed to heat. In a petition documented in Jan. 2 with the FDA, Emery also proposed the suspension of all ranitidine products sales by the agency.

Emery suggested the drugs should be transported in temperature-controlled vehicles and contain a warning about possible danger if the drug is exposed to heat when delivered.

The CEO Ron Najafi revealed he has worked as a professional witness for people charging drug manufacturers over NDMA discovered on commonly-prescribed blood pressure medications.

“This product needs to be relabeled properly,” said Najafi. “We found this molecule is temperature sensitive. That is really the bottom line. The more you heat it, the more NDMA you generate.”

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