Product: pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20250730
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated