In Brief: Miles' Mezlin
Executive Summary
Miles' Mezlin: Recalls 29 lots of sterile mezlocillin sodium due to "a typographical error in package insert labeling," the company announces March 1. Wholesalers and all U.S. nephrologists are receiving notice of the recall. The labeling for the 10,000 10-pack units of intramuscular or intravenous vials and infusion bottles "erroneously recommends that patients with impaired renal function undergoing peritoneal dialysis may receive three grams every two hours," Miles states. The actual dosing is three grams every 12 hours. Miles "has received no reports of injuries" associated with erroneously labeled Mezlin, in use since 1991, the company says...
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth