The recall is a result of concerns about the Rx laboratory’s practices that arose during a routine inspection of the compounding pharmacy by the FDA. The practices found in the inspection had the potential to contaminate products intended to be sterile.
“Administration of a nonsterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in a site-specific or systemic infection which in turn may result in hospitalization, significant morbidity, organ damage, or a fatal outcome,” the July 28 recall notice reads.
The recall affects compounded sterile drug products that were dispensed in Pennsylvania between Jan. 17 and July 10.
Read the full recall notice here.
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