AUDIENCE: Risk Manager, Health Professionals, Pharmacy
ISSUE: The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated. Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. To date, FDA is not aware of reports of illness associated with the use of these products.
BACKGROUND: Unique Pharmaceuticals products were distributed nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.
FDA investigators conducted two recent 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, which puts patients at risk (Form FDA-483s issued April 4, 2014 (PDF - 4.28MB), and June 20, 2014 (PDF - 1MB)). These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.
RECOMMENDATION: Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional. The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Unique Pharmaceuticals productsto the FDAs MedWatch Adverse Event Reporting program:
Temple, Texas Pharmaceutical Company
ReplyDeleteChallenges FDA Demand for Product Recall
TEMPLE, Texas, July 12, 2014 -- A Temple, Texas pharmaceutical outsourcing facility is challenging FDA's demand that the company recall its sterile products, which are compounded preparations, and cease operations. The FDA’s demands “epitomize unfair and arbitrary regulatory conduct,” said Unique Pharmaceuticals Ltd. CEO, Dan Volney. Temple is about 70 miles northeast of Austin, Texas.
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.”
Patients’ Health at Stake If a Recall is Required- Shortages Feared“
A recall poses patient health and safety issues for clients who rely on our compounded preparations to treat patients. Ironically, compounded preparations are in short supply. If our preparations are recalled, patients at major medical centers and in the integrated delivery networks we serve could be at risk,” Volney said. “We are confident that FDA’s request for a recall and shutdown of our operations is arbitrary and unnecessary, and is not in the interest of public health, and that UPI should be permitted to continue its sterile compounding operations.”
Unique, which employs about 90 people in the Temple area, is a voluntarily registered outsourcing facility that prepares and distributes compounded preparations for clinics, hospitals and surgery centers in the United States, primarily for anesthesia, pain management, labor and delivery and pediatrics.
Volney cited key areas of disagreement with FDA:
• FDA has distorted the facts relating to April and June inspections they conducted at the facility.
• As FDA reported, there have been no reports of any illnesses or adverse reactions from our products.
• FDA did not report it, but a lack of sterility has not been identified in a single distributed product from Unique.
• Every batch of drug products compounded at Unique has been tested for sterility, and Unique has not released a single drug product unless it has been subjected to sterility tests.
Patient Safety and Access to Important Drugs in Short Supply Are Our Highest Priorities
“Patient safety and access to important drugs that are in short supply are our highest priorities at Unique Pharmaceuticals, Ltd., and our record of safety for our compounded preparations has never before been challenged by FDA or any other federal or state entity. Hospitals, surgical centers, and other healthcare facilities rely on us to provide patients access to high quality, safe, life-saving and life-sustaining medications that are in short supply or otherwise unavailable. I hope this arbitrary and capricious action by the FDA doesn’t put patients at risk,” Volney said.