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Golden State Medical Supply is the latest generic drug distributor to announce a ranitidine recall, due to the presence of a cancer-causing impurity in the generic version of Zantac, which has essentially been removed from the market entirely in recent months.
The FDA announced the ranitidine recall on November 15, impacting all quantities and all lots of the drugs distributed by Golden State Medical Supply, which have not yet expired from the market.
The company announced the action after it was informed that high levels of N-Nitrosodimethylamine (NDMA) were found in the drugs, which contained active ingredients manufactured and supplied by Novitium Pharma, LLC.
Over the past few weeks, a steady stream of Zantac recalls have been issued by various manufacturers of prescription, over-the-counter and generic versions of the medication containing the active pharmaceutical ingredient ranitidine, which has been found to convert to NDMA, either inside the body or during storage and transport.
The FDA first warned about the Zantac NDMA problems on September 13, indicating several different versions of the heartburn drug have been found to contain the cancer-causing impurity. As a result, major retailers have removed Zantac from store shelves, and nearly every version of the medication has now been recalled.
This latest recall affects seven lots of Ranitidine HCl 150mg capsules sold in 500 count bottles with NDC 51407-097-05, and 12 lots of Ranitidine HCl 300mg Capsules sold in 100 count bottles with NDC 51407-098-01. Golden State Medical Supply indicates the affected lots were primarily sold to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies.
Golden State recommends consumers taking the capsules consult with their physician, pharmacist or healthcare provider about potential alternative treatments before discontinuing use. Consumers who bought the recalled medications are instructed to Stericycle by calling 866-382-8606 or by sending an email to Novitiumpharma6639@stericycle.com.
Consumers with questions can contact Golden State Medical Supply by calling 800-284-8633, extension 215; or by sending an email to firstname.lastname@example.org.
Zantac Cancer Problems
Zantac (ranitidine) has been on the market for decades, and is regularly used by millions of Americans for treatment of heart burn and acid reflux. However, increasing evidence now suggests the active ingredient ranitidine is inherently unstable, and may convert to NDMA when stored at high temperatures or inside the human body.
The problems with Zantac were first reported in the U.S. by the online pharmacy Valisure, which filed a citizen’s petition in September, calling on federal regulator to remove the drug from the market and provide instructions to consumers about the safe disposal of the medication to avoid widespread water contamination. The group also sent a copy of the petition to the World Health Organization, indicating that Zantac should be considered a human carcinogen.
According to independent testing by Valisure, levels of NDMA in one Zantac 150mg tablet may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical.
Excessive levels were detected across all brands of Zantac and all lots, and Valisure indicated research dating back 20 years has included warning signs about potential problems with the drug.
While drug makers and federal regulators indicate that they are continuing to investigate the Zantac problems, many consumers are now questioning whether they may have avoided a cancer diagnosis if other available alternative treatments for heartburn had been used.
A growing number of Zantac lawsuits are now being pursued by individuals diagnosed with bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer and other problems impacting the digestive tract as NDMC from ranitidine moved through the body.