This may not come as a surprise to some, but another compounding pharmacy has issued a recall on tainted products. On March 25th, Pallimed Solutions, Inc., a compounding pharmacy, announced a recall of several of its sterile compound products distributed since January 1st.
This recall came as a result of state and federal inspections that revealed certain injectable drugs, that must be sterile, were contaminated with unidentified particulate matter. In response to the findings and the pharmacy’s history of products with issues, the Massachusetts Board of Pharmacy has ordered Pallimed to stop producing sterile compounded drugs; although Pallimed continues to produce non-sterile products.
Yesterday, it was revealed that Pallimed’s drug recall is more expansive than the company originally reported. In fact, the contaminated products were distributed to 21 states, including Maryland and Virginia.
These products are used for a wide range of uses, including testosterone therapy, vitamin injections, eye treatments, and sterile water used for injections.
The contaminant has not been identified as of yet, but according to the latest announcement, they could cause “damage or obstruction to blood vessels, which could induce emboli, cause systemic allergic reactions, or cause tissue responses to foreign material.” To find out if you could be at risk, check the FDA’s list of recalled Pallimed products.
This finding was a result of increased efforts by regulators to step up inspections after the deadly meningitis outbreak that resulted in 50 deaths and over 700 injuries nationwide, including several casualties in Maryland and Virginia.
Luckily, no injuries have been reported as a result of the contamination of Pallimed products and this recall is preemptive. However, this goes to show the need for increased regulation of compounding pharmacies to ensure that patient safety is being prioritized over profit-saving shortcuts. In the past, Pallimed produced a pain killer that was too potent, resulting in two hospitalizations as well as a generic form of Viagra that was made with improper materials. Unfortunately, Pallimed is just one example of compounding pharmacies that don’t follow standards or regulations.
And we’re not the only ones who think so. Reuters reports FDA Commissioner Margaret Hamburg’s official blog post, expressing hope that a Senate committee would address these issues with new legislation. We also hope that measures are taken to hold compounding pharmacies responsible for promoting the safety of their products and consumers.