FDA issued a letter, this big variety may face de-listing!

　　On April 1, the FDA issued a letter requiring manufacturers to immediately withdraw all prescriptions and OTC retintin drugs from the market, the reason for this action is that the FDA has determined that if some renitin products are stored in environments above room temperature, impurities in them increase with storage time and expose consumers to unacceptable levels of impurities
The FDA's new testing and evaluation of information from third-party laboratory-confirmed Renitine NDMA levels increases even under normal storage conditions, and finds that NDMA increases significantly when samples are stored at higher temperatures, including products that may be exposed by drugs during sales and patient handling
Tests also show that the longer the renittine is placed, or the earlier the production time, the higher the level in ndMA These conditions may cause NDMA levels in renitin to rise and exceed acceptable daily intake limits
In fact, the FDA's decision to recall Renitin products is well-documented Back in the summer of 2019, the FDA learned through a laboratory test that Renitin products contained contamination of NDMA, but found that Renitin's drugs contained low levels of NDMA At the time, the agency chose to continue its investigation
In September, The online pharmacy and testing laboratory Valiure notified Zantac and other heartburn-treating drugs of potentially carcinogenic impurities and filed a citizen's petition for the FDA to recall Sanofi's Zantac and all other Renitin products That month the FDA issued a warning to the public of the risks of using renitin drugs and prompting doctors and patients to consider other OTC and prescription drug treatments that can replace renitin
In October of the same year, Sanofi voluntarily recalled its Renitin products from pharmacies in the United States and Canada, as well as from a number of pharmacy retailers, including CVS, Walgreens and Rite Aid In addition, GlaxoSmithKline and Novartis have recalled or stopped production of Renitin tablets Also at the end of 2019, Glenmark Pharmaceuticals of the United States announced a voluntary recall of all unexpired renitin tablets
In early January 2020, the lab, Emery Pharma, also filed a citizen's petition informing the FDA that its tests confirmed that even if the renitin drug was well packaged, the level of its suspected carcinogen NDMA would increase if stored in a high temperature environment However, according to the FDA's requirements at the time, if tests showed that NDMA levels were higher than the acceptable daily intake (Renitin9 96 ng or 0.32 parts per million), the company was advised to recall Reinitin
The industry believes that the larger retintin may face de-listing in the light of the previous recall of some of its products and the current decision to recall all Renitin etodrugs sold in the United States In addition to sending a letter to all renitin manufacturers asking them to withdraw their products from the market, the FDA recommends that consumers taking OTC renittin stop taking all tablets or liquids they hold and dispose of them appropriately and stop buying them
According to public information, Renitin was developed by Allen and Hanbury Ltd., a former research firm owned by GlaxoSmithKline, which was initially listed in the UK in October 1981. Clinically, renitin can be used to treat duodenal ulcers, stomach ulcers, reflux esophageal itisand and other diseases that cause excessive secretion of stomach acid
According to Evaluate Pharma's previous report, Renitin ranked 7th in the top 10 drug with cumulative sales of $94.72 billion in 2018, behind well-known varieties such as Attovastatin, doctade, inasip
According to the database information of the State Drug Administration, Renitin domestic drug approval number reached 579, Sunflower Pharmaceuticals, Sapu Ais, China Resources Double Crane, Connbe, Huaren Pharmaceuticals, Sanofi and other well-known pharmaceutical companies are holding approval.