Heavyweight products recalled

Source: FDA / cypress blue Finishing: looking forward Newest! Two pharmaceutical companies recalled ranitidine Recently, three NDMA related recall notices have been released on the FDA website, involving drug companies such as mylan, Northwind and appco, and products such as nizatidine capsule, ranitidine tablet and ranitidine capsule According to the recall information updated by fda1 on August 8, appco Pharma LLC voluntarily recalled ranitidine hydrochloride capsule, a prescription drug Northwind pharmaceuticals voluntarily recalled ranitidine prescription drugs (150 mg and 300 mg) manufactured by glenmark pharmaceutical Inc Mylan voluntarily recalled the prescription drug nizatidine capsules because they may contain an unacceptable nitrosamine, N-nitrosodimethylamine (NDMA) NDMA is an N-nitrosodimethylamine, which belongs to a nitrosamine impurity - according to the results of laboratory tests, NDMA is classified as a possible human carcinogen, and NDMA is a known environmental pollutant, which exists in water and food (including meat, dairy products and vegetables) It is understood that acute N-nitrosodimethylamine poisoning can cause liver injury, decrease of platelet count and increase of transaminase concentration, as well as headache, fever, vomiting, abdominal pain, scattered subcutaneous hemorrhage, drowsiness, nausea, diarrhea and other symptoms In addition, long-term intake of small doses of N-nitrosodimethylamine also significantly increased the risk of liver cancer Recall of several pharmaceutical companies around the world According to cerberyl, FDA issued a statement as early as September 13, 2019 to remind ranitidine of NDMA in samples Subsequently, drug regulatory agencies in Canada, South Korea, India and Italy also expressed their opinions on the issue of NDMA impurities Since then, FDA has released voluntary recall information and laboratory test results for many times According to the information on FDA's website, since the NDMA event in 2018, FDA has released 19 NDMA related recalls According to incomplete statistics, up to now, Novartis, GSK, Sanofi, TIWA, Dr riddy and other pharmaceutical companies have recalled ranitidine "This recall of multiple batches of ranitidine film coated tablets from pharmacies will involve 26 countries," Sanders told the media earlier In particular, Sandoz does not sell ranitidine film coated tablets in the Chinese market, so the Chinese market will not be affected by the recall " It is worth noting that the FDA also cautions that not all ranitidine drugs sold in the United States are recalled According to FDA official information, if the test shows that the NDMA level is higher than the daily acceptable intake (ranitidine 96 ng or 0.32 parts per million), FDA recommends that the company recall ranitidine Ranitidine is an over-the-counter (OTC) and prescription drug Ranitidine is an H2 (histamine 2) blocker that reduces the amount of acid produced by the stomach Over the counter ranitidine is approved to prevent and relieve heartburn caused by acid and stomach acid Ranitidine is approved for a variety of indications, including the treatment and prevention of gastric and intestinal ulcers and the treatment of gastroesophageal reflux disease According to public information, ranitidine was first developed by Allen & hanburys Co., Ltd where John Bradshaw is based The original research company is GlaxoSmithKline, which was listed in the UK as early as October 1981 According to the previous report of evaluate Pharma, ranitidine ranked 7th in the top 10 drugs with accumulated sales revenue of US $94.72 billion as of 2018, ranking behind star drugs such as atorvastatin, rituximab and etanercept The FDA does not currently require individuals to stop taking ranitidine However, patients who want to stop using ranitidine should discuss other treatment options with healthcare professionals Consumers taking OTC ranitidine may consider using other OTC products approved for their condition So far, FDA tests on alternative samples have shown that there is no NDMA in pepid, Tagamet, Nexium, prevacid and Prilosec.