Yet another compounding pharmacy has issued a recall for all of its drugs, after inspectors determined that they may be contaminated and pose a potential health risk.
The FDA and Massachusetts Department of Public Health have found foreign matter in drug vials at a facility operated by Pallimed Solutions, Inc, of Woburn, Massachusetts. As a result, a recall (PDF) has been issued for all products produced by the company and the company’s compounding activities have been suspended.
The Pallimed recall affects 16 compounded drugs distributed by the company. Most of the drugs focused on the treatment of erectile dysfunction. On its website, the company states that there are no indications that any of the recalled drugs have been contaminated.
The recall comes as more and more attention is focused on compounding pharmacies nationwide in the wake of a deadly fungal meningitis outbreak. Investigators believe that outbreak started at another Massachusetts compounding pharmacy, New England Compounding Center (NECC), which was shut down in early October 2012 after contamination led to a recall for all of its products.
According to the most recent update by the U.S. Centers for Disease Control and Prevention (CDC), the NECC fungal meningitis outbreak has killed 51 people and sickened at least 730 throughout the United States. However, not all of the victims had meningitis, as hundreds were also affected by paraspinal infections allegedly caused by the contaminated epidural steroid injections blamed for the outbreak.
NECC is facing a number of fungal meningitis lawsuits filed by individuals who received the contaminated epidural steroid injections, as well as criminal charges, and has declared bankruptcy.
In the wake of that outbreak, states and the FDA have cracked down on compounding pharmacies. In many cases, the pharmacies have been caught selling products nationwide and acting like stealth drug manufacturers, when they are supposed to only supply drugs to local hospitals when there is no mass-produced equivalent on a per-prescription basis.
Last week, FDA Commissioner Margaret Hamburg called on congress to provide the FDA with more regulatory power over compounding pharmacies, in order to prevent another deadly outbreak.