Pennex recall
Executive Summary
Private label firm complies with FDA request to formally conduct Class II recall of bacterially contaminated OTC liquid antacid 18 months after Pennex conducted an informal "recall" without notifying the agency ("The Pink Sheet" July 29, T&G-13). Verona, Penn.-based Pennex Products contacted the three distributors of the contaminated lot -- Schein Pharmaceutical, Medisave Pharmacal, and Texas Drug Reps -- in January 1990 to request the return of all units. Pennex destroyed all the units in February 1990 and discontinued marketing the product in July 1990.
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