July 21, 2014 — Unique Pharmaceuticals, Ltd. has recalled medications because they may not be sterile, according to a Safety Alert.
According to the U.S. Food and Drug Administration (FDA), two recent inspections of the facility in Temple, Texas found evidence of “insanitary” conditions that could result in contaminated medications:
“These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.”
On July 11, the FDA asked Unique Pharmaceuticals to recall all non-expired lots of sterile medications and stop producing new medications until problems are fixed. The company initially refused, but agreed to issue a recall on July 19.
No illnesses have been linked to the products. Healthcare professionals should check inventory for the recalled products and quarantine them. Patients who received medications from this facility should contact their healthcare providers with any concerns.
In the past, compounding pharmacies were small-scale operations that custom-mixed medications for individual patients with a prescription. But in the last decade, a growing number of compounding pharmacies have started mass-producing medications and distributing them across state lines to hospitals and clinics.
Unique Pharmaceuticals was registered as an “outsourcing facility” under a law passed in November 2013 expanding federal oversight of the compounding industry. The law was passed in response to a massive outbreak of fungal meningitis that infected over 750 people in 20 states, including more than 60 who died. The outbreak was traced to drugs that were mass-produced by one pharmacy in Massachusetts.
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The Schmidt Firm, PLLC is currently accepting compounding pharmacy induced injury cases in all 50 states. If you or somebody you know has been injured by a contaminated medication, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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