All Sterile Products Recalled
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals of a voluntary recall of all non-expired sterile products manufactured by Pharmakon Pharmaceuticals.
From March 4, 2016, to April 15, 2016, the compounded products were distributed to hospitals nationwide. The indications of the products and the forms they come in are many.
Pharmakon suggests the discontinuation and quarantine of these products. The company can be contacted at 888-660-6715, extension 251.
In April, the FDA issued a warning regarding the cessation of use all sterile drug products manufactured by Pharmakon Pharmaceuticals in the wake of an inspection visit from the agency. That came after a February recall of super-potent morphine sulfate, prompted by reports of serious adverse events. The product in question was almost 2,500% the potency the label indicated. Investigators also observed poor sterile production practices, environmental contamination, and what it termed “other deficiencies.”
The FDA then recommended the cessation of “sterile operations until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile.”
Click here to read the notice.
--Stephanie Vaccaro
Reference:
1. U.S. Food and Drug Administration. FDA announces Pharmakon Pharmaceuticals’ nationwide voluntary recall of purportedly sterile drug products. www.fda.gov. Accessed May 11, 2016.
