FDA has posted on www.fda.gov a July 19, 2014 press statement from Unique Pharmaceuticals, which reports a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products.
“Unique is initiating the recall due to FDA’s concerns associated with Unique’s compounding facilities and compounding processes that FDA contends present a lack of sterility assurance and were observed during recent FDA inspections,” the statement reports.
Unique reports that to date, the company has received no reports of injury or illness associated with the use of its sterile preparations. “Patient safety is Unique’s highest priority, and Unique has proceeded with this voluntary action out of an abundance of caution,” the statement reports.
The recall includes all sterile compounded preparations that Unique has supplied to its customers within expiry. Non-sterile preparations are not affected by this recall.
The affected products were distributed in syringes, vials, and bags.
On July 11, FDA posted a notice alerting health care professionals not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., as they may be contaminated. FDA reported that investigators conducted two inspections of the Unique Pharmaceuticals facility and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company. These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices, FDA reported. Two FDA-483s were issued on April 4, 2014, and June 20, 2014.
In a statement dated July 12, 2014 and posted on the Unique Pharmaceuticals website, the company challenged FDA’s demand that the company recall its sterile products. FDA’s demands “epitomize unfair and arbitrary regulatory conduct,” said Unique Pharmaceutical Ltd. CEO, Dan Volney in the statement.
The demand for recall is “based on erroneous interpretation of standards by the FDA and their refusal to review our documents that confirm the safety and sterility of our products,” Volney said. “Many industry consultants tell us our products are safe. And no sterile preparations that failed valid sterility tests have been distributed. More importantly, our sterility test results, performed on every batch produced, confirm our products are sterile.”
The statement further details Unique Pharmaceutical’s points of disagreement with FDA, the agency’s inspection of the facility, and the company’s response to the findings of the inspection.
Unique Pharmaceuticals voluntarily registered as an outsourcing facility in accordance with the Drug Quality and Security Act.