Medistat RX Voluntary Recall:
Compounding pharmacies are once again under scrutiny on a national level as Medistat RX voluntarily recalled all sterile drug products that it had produced last week. The sterile compounding pharmacy located in Foley, Alabama, recalled all manufactured and compounded medications which it distributed between November 1st, 2014 and September 3rd, 2015. It was a voluntary recall announced by the FDA pertaining to all unexpired compounded drugs produced by the pharmacy because of possible contamination.
It must be noted that although the recall is classified as “voluntary”, the FDA had previously performed a routine inspection last September 2014 and found “deficiencies in good manufacturing practices”. That inspection resulted in a notification to Medistat RX that the deficiencies were found in their manufacturing practices and that the FDA would be re-inspecting them (via FDA Form 483). The pharmacy chose to voluntarily cease all sterile compounding operations on September 1st, 2015. Additionally, the FDA announced that it has received several reports regarding harmful “events” that have been linked to medications compounded by Medistat RX. The FDA also stated that it would protect public health in the case by working jointly with the Alabama Board of Pharmacy in any subsequent actions it takes.
Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case which drew a substantial amount of national media attention, 48 patients actually died and up to 14,000 people may have received the contaminated injections.
If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.