All sterile products made by Beacon Hill Medical Pharmacy d/b/a Rxtra Solutions, a compounding pharmacy in Southfield, Mich., have been recalled because the Food and Drug Administration (FDA) has raised questions about the sterility of the products.
Microbial contamination of products that are intended to be sterile can cause serious infections that can be life threatening. To date, there have been no reports made to Beacon Hill of any adverse reactions related to the recall, nor has any evidence of contamination been found in the recalled products or any products previously prepared by the pharmacy.
The recall affects more than 100 products that are generally prescribed to patients receiving IV solutions and hormone replacement therapy. The products were distributed to medical facilities across the country. A list of all recalled sterile products can be found here.
Compounding pharmacies use FDA-approved drug ingredients to custom-mix drug products based on physicians’ prescriptions. The pharmacies are regulated by state pharmaceutical boards; however, the FDA has begun to inspect these pharmacies that mass-produce products and distribute them across state lines after a similar pharmacy, New England Compounding Center (NECC), was found to have manufactured contaminated steroid shots for the treatment of back and joint pain.
About 18,000 tainted shots were distributed to medical facilities in 23 states between late May and late September 2012. To date, at least 749 people have develop fungal infections including fungal meningitis, and 61 have died.
Anyone who has received any of the most recently recalled products and who is experiencing any side effects is encouraged to file a report with the FDA’s MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.