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