Another prescription-strength Zantac recall for, maybe, having too much of a carcinogen
All unexpired lots of 150mg and 300mg ranitidine (over-the-counter brand name: Zantac) tablets distributed by by Glenmark Pharmaceutical were recalled late Tuesday for possibly having too much NDMA.
Patients are recommended to immediately stop using and then discuss alternate treatment with their doctors.
Presence of NDMA (N-nitrosodimethylamine), classified as a “probable human carcinogen,” has caused numerous recalls of ranitidine in all forms — tablet, capsule, liquid, prescription and over-the-counter. The drug helps deal with ulcers and reflux in the digestive system.
Glenmark “will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers,” the company-written, FDA-posted recall notice says. “As a further precautionary measure, Glenmark ceased distribution of its Ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.”
This covers 928 lots, 16 made by Glenmark in Goa, India, and 912 made in Strides Pharma Science Limited in Puducherry, India. Patients should look at the label on the bottle for the NDC number.
The 150mg tablets NDC Nos.: 68420-248-60; 684620-248-01; and 684620-248-05. Expiration dates are from 12/2019 to 5/2022. They come in 60-count, 100-count and 250-count bottles.
The 300mg tablets NDC Nos: 684620-249-30; 684620-249-01; and 684620-249-20. Expiration dates are from 12/2019 to 6/2022. They came in 30-count, 100-count, 250-count bottles.
To return tablets, call Qualanex at 888-504-2012, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
Those with questions or who want to report quality problems can call Glenmark at 888-721-7115, Monday through Firday, 9 a.m. to 6 p.m. or email GlobalCustomerService@glenmarkpharma.com.
This story was originally published December 18, 2019 at 11:43 AM with the headline "Another prescription-strength Zantac recall for, maybe, having too much of a carcinogen."
