REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Essential Wellness Pharma's Progesterone Injection Fails Sterility Assurance
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma initiated a Class II recall for its Progesterone 100 mg/mL in Corn Oil Injection due to a critical lack of sterility assurance. This 2015 nationwide recall, terminated in 2017, stemmed from poor sterile production practices at its Peoria, IL facility. For procurement and regulatory leaders, this highlights the severe risks associated with compounded sterile preparations and underscores the imperative for rigorous supplier qualification and ongoing oversight in this sector.
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