Wave after wave! Another problem with ranitidine, another drug company chose to recall!

Five months ago, in August 2019, the FDA expanded its investigation of impurities in generic drugs on the market On September 13, the FDA issued a safety warning that it was aware of some ranitidine drugs, including the brand Zantac, which contain N-dimethylnitrosamine (NDMA) impurities After the safety warning was issued, many multinational pharmaceutical companies voluntarily recalled their products, among which Dr Reddy pharmaceutical company suspended its global supply of ranitidine until the end of the FDA investigation; Sanders voluntarily recalled all ranitidine batches within the affected validity period in the United States; Apotex pharmaceutical company in Canada voluntarily recalled 75mg and 150mg GlaxoSmithKline voluntarily recalled its ranitidine drugs sold in global markets, including India Today, according to the information released by FDA, ranitidine hydrochloride produced by a ppco pharmaceutical company found that the concentration of NDMA exceeded the standard, and announced the voluntary recall of all batches of ranitidine hydrochloride capsules of 150 mg and 300 mg The following is the full text and translation of the notice released by FDA Appco Pharma LLC (appco) is voluntarily recalling all quantities and lots, within experience, of ranidine hydraulic capsule to the consumer level Ranidine hydraulic capsule are being admitted because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable level Daily intake levels established by the FDA, based on FDA validated tests To date, appco has not received any reports of adverse events related to use of the product as part of this recall Appco Pharma LLC (appco) voluntarily recalled all batches of ranitidine hydrochloride capsules to consumers Ranitidine hydrochloride capsules were recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) concentrations higher than the daily acceptable intake levels determined by FDA tests So far, appco has not received any adverse event reports related to the use of the recalled products   Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, Risk statement: according to laboratory test results, NDMA is classified as a possible human carcinogen (a possible carcinogen) NDMA is a known environmental pollutant in water and food, including meat, dairy products and vegetables   Ranitidine Hydrochloride in strengths of 150 mg and 300 mg, is a prescription-only oral medication indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, The specifications of ranitidine hydrochloride in this recall are 150 mg and 300 mg This drug is a prescription drug for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, postoperative peptic ulcer, and zhuoei syndrome And other diseases that need to reduce gastric acid secretion The products subject to recall are listed below and are packaged in bottles The product can be identified by checking the product name, count / BOT, manufacturer details and batch or lot number on the BOT containing these products The product can be identified by checking the product name, quantity, or manufacturer details and batch or batch number on the bottle containing the product Ranidine capsules 150 mg & ranidine capsules 300 mg were distributed nationwide   Appco is notifying their marketing partner (ANI Pharmaceuticals, Inc.) by phone, email or other communication with recall notification communication ANI Pharmaceuticals Inc., on behalf of Appco Pharma LLC, will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts Appco is arranging for return of all recalled products to ANI Pharmaceuticals, Inc Instructions for returning recalled products are given in the recall letter Anyone with an existing inventory will be asked to immediately stop distribution and return any stock to ANI Pharmaceuticals, Inc by contacting Stephen bitter at stephen.bitter@animharmaceuticals.com or 218-634-3655 (between 8 to 5pm CST) All the admitted product shall be sent to: appco is notifying the marketing partner ani pharmaceuticals, Inc by phone, email or other means of recall notification Ani Pharma will, on behalf of appco Pharma, notify dealers and customers by phone and in writing, immediately stop the sale of specific batches recalled and notify their sub accounts Appco is arranging to return all recalled products to ani pharmaceutical Instructions for returning recalled products are given in the recall letter Anyone and existing inventory will be required to stop selling immediately and return all inventory to ani Pharmaceutical by contacting Stephen bitter All recalled products shall be sent to: ani pharmaceuticals Attn: Stephen bitter 210 Main Street West baudette, Mn 56623 consumers that have product which is being recalled should stop using / return to place of purchase and speak to their physician or pharmaceutical about alternate health treatment options   Consumers with questions regarding this recall can contact Appco at: (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: pv@appcopharma.com or at ANI Pharmaceuticals, Inc at 1-800-308-6755 or pvsupport@safetycall.com Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product Consumers should contact their doctor or healthcare provider if they encounter any problems that may be related to the use or use of this drug Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch adverse event reporting program either online, by regular mail or by fax Complete and submit the report online complete and return to the address on the pre addressed form, This recall is being conducted with the knowledge of the U.S Food and drug administration Reference source: appco Pharma LLC issues voluntary nationwide recall of ranidine hydrochloride caps 150 mg and 300 mg due to an elevated amount of unexpected security, N-nitrosodimethylamine (NDMA) said: This article only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.