 on June 18, 2019 that it was voluntarily recalling all unexpired products that were intended to be sterile because of a lack of sterility assurance. The recall follows an FDA inspection of the company’s Weeki Wachee, FL facility that found insufficient environmental controls, potential cross contamination, and a lack of process validation.

	While the company has not received any reports of adverse events as of date, administration of nonsterile drug products that were intended to be sterile could result in serious infections. The company stated in a press release that the recall was being conducted out of an “abundance of caution.” Adverse events may be reported to FDA through its MedWatch program.

Adverse Events and Recalls

Aseptic/Sterile Processing

Audits and Inspections

Industry News

PharmTech News

Quality Assurance/Quality Control

Quality Systems

Regulatory Authority Actions

Regulatory/GMP Compliance

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.