Unique Pharmaceuticals Recalls All Sterile Drugs July 21, 2014 — Drugs sold by Unique Pharmaceuticals may not be sterile and should not be used, according to a Safety Alert issued by the U.S. Food and Drug Administration (FDA).

Unique Pharmaceuticals Ltd. is a compounding pharmacy that is based in Temple, Texas. They provide custom medications for hospitals and clinics nationwide.

The FDA recently conducted two inspections of the Unique Pharmaceuticals facility and observed insanitary conditions that might allow a contaminated medication to reach consumers:

“These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.”

Unique Pharmaceuticals initially refused to recall all non-expired lots of sterile drug products, despite a request from the FDA. Unique Pharmaceuticals also refused to stop making “sterile” drugs until sufficient corrections are made. On July 19, they agreed to issue a recall.

Although no reports of illness have been linked to the products, patients who have been treated with these products should contact a healthcare professional immediately with any concerns.

According to the FDA, the company is registered as an “outsourcing facility” under a law passed in November 2013 that increased federal oversight of the compounding industry — especially companies that distribute products across state lines. The law was passed in response to an outbreak of fungal meningitis in 2012 that infected over 750 people and caused at least 60 deaths in 20 states. The outbreak was traced to a compounding pharmacy in Massachusetts that was distributing non-sterile epidural steroid injections.

The FDA recommends that healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and do not give them to patients.

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