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SoviHep is the first sofosbuvir brand launched in India by Zydus in the year 2015. [4] In 2019, injectable ketorolac tromethamine manufactured by Zydus (Cadila Healthcare) was recalled due to microbial growth. [13] In 2020, Zydus Cadila's drug Desidustat received approval by the USFDA to initiate clinical trials on cancer patients. [14]
Zydus Lifesciences and Sun Pharmaceuticals have entered an agreement in October 2023 to co-market Desidustat. Sun Pharma will sell the drug as Rytstat, while Zydus will continue to sell it as Oxemia. [6]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
Ketorolac, sold under the brand name Toradol, Acular and Sprix, among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain. [3] [4] Specifically it is recommended for moderate to severe pain. [5]
Ready-to-eat meat and poultry items produced from June 19, 2024, to October 8, 2024, with establishment numbers "51205 or P-51205" on the packaging are subject to the recall.
In medicine, tromethamine is occasionally used as a drug, given in intensive care for its properties as a buffer for the treatment of severe metabolic acidosis in specific circumstances. [ 4 ] [ 5 ] Some medications are formulated as the "tromethamine salt" including Hemabate ( carboprost as trometamol salt), and " ketorolac trometamol". [ 6 ]
More than 500 types of frozen waffles sold by in-house brands at large retailers, including Publix, Target and Walmart, have been recalled over possible listeria contamination.