Testosterone Cypionate

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy initiated a Class II recall for multiple lots of Testosterone Cypionate In Sesame Oil 200mg/ml injectable due to a lack of sterility assurance. This Murrieta, CA-based firm's voluntary action, impacting patients in CA, ME, and TX, underscores critical quality control vulnerabilities in compounded sterile preparations. Procurement and regulatory teams must scrutinize supplier sterility protocols to mitigate supply chain risks.

Sun Pharmaceutical Industries, Inc. initiated a Class II recall (D-0787-2020) of Testosterone Cypionate for Injection, USP, distributed across the US. The action stemmed from cGMP deviations, as released lots were manufactured under conditions similar to a rejected OOS lot. This event, terminated in August 2020, underscores critical supply chain and quality assurance challenges for procurement and regulatory leaders.