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News
New Dosage Strength of Cassipa Sublingual Film Approved
The FDA has approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. This now provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.
https://www.americanpharmaceuticalreview.com/1315-News/353410-FDA-Approves-New-Dosage-Strength-of-Buprenorphine-Naloxone-Sublingual-Film/
Despite FDA Inspections, Thousands of Medicines are Recalled After Reaching Patient
In a 3,500-word report, Kaiser Health News examines recalls of medicines that have reached American consumers after FDA inspections of manufacturing facilities. Kaiser's investigation shows that "since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles, and vials that have entered the U.S. drug supply and made their way to patients' medicine cabinets, hospital supply closets, and IV drips."
Kaiser adds that "the FDA declined to be interviewed for this story, but responded to written questions" through spokesman Jeremy Kahn, who wrote, "While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs."
https://khn.org/news/how-tainted-drugs-reach-market-make-patients-sicker/
Sun Pharma Issues Recall of IV Muscle Relaxant After Glass Fragments Found
India's Sun Pharmaceuticals has issued a voluntary recall of four lots of Vecuronium Bromide for Injection after particulate matter identified as glass was found in the product. The recall includes three lots of 10 milligrams of lyophilized powder and one lot of 20 milligrams of lyophilized powder, both of which must be reconstituted before being administered.
The recall posted on the FDA's website explains that the product was distributed nationwide in the U.S. to wholesale customers and medical facilities. It began notification of the recall earlier this month.
https://www.fiercepharma.com/manufacturing/sun-pharma-issues-recall-iv-muscle-relaxant-after-glass-fragments-found
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