Acting FDA Commissioner So, they started testing ranitidine capsules soon after they learned of the possible impurity. Ranitidine, sold under the trade name Zantac among others, is a medication that decreases stomach acid production. N-nitrosodimethylamine (NDMA), found in ranitidine capsules, is a substance that has the potential to cause cancer. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.The Ranitidine Tablets, USP subject to the recall can be identified by the NDC number on the product label. Sandoz is recalling Ranitidine Hydrochloride capsules that are contaminated with NDMA, a probable cancer causer. As part of its investigation, the FDA has posted a testing procedure, that can help industry and regulators to detect The agency has also asked companies to start examining the NDMA levels in ranitidine in their own laboratories and to send ranitidine samples to the FDA for further testing by agency scientists. Prescription ranitidine is approved to treat stomach or intestinal ulcers and to treat gastroesophageal reflux disease. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. The recalled lots were sold to AmerisourceBergen, McKesson and … And the presence of nitrosamine in these 14 lots of medicine was the reason for this recall. September 24, 2019. So, categorized as a possible human carcinogen. It 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. On September 24th 2019, the FDA announced a voluntary recall of 14 lots of prescription ranitidine capsules from manufacturer Sandoz, Inc. And analyzing their potential effect on patients taking this medicine. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The recall affects 7 lots of its ranitidine HCl 150 mg capsules and 12 lots of ranitidine HCl 300 mg capsules. Aurobindo recalls Ranitidine tablets, capsules and syrup The medications are contaminated with a probable cancer-causer. Twitter @Areeba94789300Please consider supporting us by disabling your ad blocker CTRL + SPACE for auto-complete. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.Glenmark is committed to product and consumer safety. That prevents and relieves heartburn related to sour stomach and acid ingestion.Ranitidine capsule has got approval for prescription in case of multiple indications. Prescription ranitidine is only available as a generic. Besides these, the FDA also gives the best recommendations to the people as quickly and precisely as possible.The acting FDA commissioner has also said that they will continue to inspect and work to make sure that such types of impurities do not surpass acceptable limits. Photos are attached below.Glenmark is notifying its direct customers by mailing (UPS Overnight) a recall notification letter and is arranging for return of all recalled product. Ranitidine capsules are in use for decreasing the amount of acid made by the stomach cells. While the appropriate measures will be taken by the FDA and manufacturers based on the investigation results.The FDA has also encouraged health care professionals and patients to report any adverse effects to the agency’s Areeba is an independent medical and healthcare writer. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall: FDA identifies lapses in the drug quality that can place patients at risk. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:The affected Ranitidine Tablets were distributed directly to Wholesalers, Distributors, Retailers and Repackagers nationwide.The 150mg products product are packaged in bottle packs of 60âs, 100âs and 500âs, whereas, the 300mg products are packaged in bottle packs of 30âs, 100âs and 250âs. Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product.
Tweet. Anyone with an existing inventory of the product should quarantine the recalled lot immediately.Customers who purchased the impacted product directly from Glenmark and consumers can call Qualanex at 1-888-504-2012Call: 1-888-504-2012 Monday â Friday, 9:00 am â 5:00 pm, EST to arrange for product return.Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options.Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Glenmark Drug Safety by phone at Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am â 6:00 pm, US EST, or e-mail at Write CSS OR LESS and hit save.