By Estel Grace Masangkay
The U.S. Food and Drug Administration (FDA) announced that it is issuing a voluntary, nationwide recall of all non-expired, supposedly sterile drugs produced and distributed by Unique Pharmaceuticals.
The affected lots include 86513, N-Acetyl Cysteine 20 percent, which was supplied by the company nationwide. The recall resulted from two inspections of the company’s facility, in which the FDA found unsanitary conditions that affect sterility assurance and quality. “These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices,” stated the agency.
Earlier this month the FDA sent a formal request to the company to conduct a recall of all affected products. Unique Pharmaceuticals has agreed to initiate the recall and to stop sterile compounding operations at the facility in response to the FDA’s request. In a press release, the company stated, “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… Unique will be notifying customers by phone, fax, mail, or personal visits to return the products to the Company.”
The agency urged healthcare professionals to examine their medical supplies and quarantine any sterile drugs from Unique Pharmaceuticals. “Using these products puts patients at an unacceptable risk for serious infection. We urge health care professionals to follow recall instructions issued by the firm,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
There have been no reports of illness or adverse events from use of the affected products to date. The FDA encourages both healthcare professionals and consumers to report quality problems related to the contaminated products to the FDA’s MedWatch Adverse Event Reporting program.