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Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues.Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers. The impurity detected in the finished drug product is N-nitrosodimethylamine (NDMA). The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) at bedtime. The safety and effectiveness of ranitidine oral solution USP have been established in the age-group of 1 month to 16 years. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Pharmacies that have received the affected lot should contact (877) 475-5864 to receive a return packet. Available for Android and iOS devices. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled:Rantidine Tablets, USP 150mg,190(2x95)Tray (Sam’s Club)Ranitidine Tablets, USP 150 mg 220 CT Btl (Walmart)Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart)Ranitidine Tablets, USP 150 Tab 200Ct Btl (Walgreens)Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens)Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS)Ranitidine Tablets, USP 75mg Tab 30Ct Btl (Walgreens)Ranitidine Tablets, USP 75mg Tab 80Ct Btl (Walgreens)Ranitidine Tablets, USP 75 TAB 80ct Bottle NG (CVS)Ranitidine Tablets, USP 75 TAB 160ct Bottle NG (CVS)Ranitidine Tablets, USP 150 Tablet 130ct Bottle NV (Walmart)Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s)Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s)Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target)Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison)Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison)If consumers have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. Prescription ranitidine syrup, a form of the digestive aid sold over the counter as Zantac, has been recalled along with another over-the … This recall is being conducted with the knowledge of the U.S. Food and Drug Administration . 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 60’s, 100’s and 500’s, whereas, the 300mg products are packaged in bottle packs of 30’s, 100’s and 250’s. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Syrup was distributed nationwide to wholesalers/distributors.Lannett is notifying its distributors and customers via email and via the Lannett website, and is arranging for return of all recalled products. Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL … This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. These forward-looking statements are based on current expectations of future events. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. Instructions for returning recalled products are given in the recall letter. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.The affected Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) were distributed directly to Wholesalers, Distributors, Retailers and Repackagers.Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. © 2020 WPMT-TV. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
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