Texas-based Unique Pharmaceuticals, an FDA-registered outsourcing facility, last week recalled all of its unexpired sterile products but only after initially sparring with FDA about whether the action was warranted. A drug safety advocate said the incident highlights the agency's need for mandatory drug recall authority because compounders may be more reluctant than their drug industry counterparts to voluntarily recall drugs. FDA requested the Unique Pharmaceuticals recall on July 11 following two inspections in the preceding months, according to a letter...
You've followed a link to an article or document on InsideHealthPolicy.com.
There are two ways you can access this content.
Subscriber Login
If you are an InsideHealthPolicy.com subscriber, or you have an active trial subscription, please login here:
Take A Trial Subscription
If you haven't already had a trial subscription to InsideHealthPolicy.com, you can sign up for one right now. Just click on the link below to get started -- you'll get full access for one month, including access to our newsletters, Inside CMS and FDA Week, plus daily news updates by e-mail and much, much more.
Sign up for a trial subscription.