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Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
Innoveix Pharmaceuticals, Inc. announced on October 10, 2019 that it is voluntarily recalling all sterile compounded drug products, within expiry, because of a lack of assurance of sterility.
Recalled products include injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2, which were distributed to customers and healthcare facilities. The recall was initiated after an FDA inspection was conducted at the facility.
While the company states the recall is out of “an abundance of caution” and it has not received any notice of adverse events, use of product that is intended to be sterile but is not sterile may result in serious and life-threatening infections. The company is advising customers to stop use of the products and to return any product they may have for a full refund. Adverse events may be reported to FDA through the agency’s MedWatch program.