REGULATORY INTELLIGENCE·Recall
SCA Pharmaceuticals Recalls PHENYLephrine HCl Injection Due to Sterility Concerns, Impacting US Supply Chains
SCA Pharmaceuticals initiated a Class II recall for 8,050 syringes of PHENYLephrine HCl Injection from its Windsor, CT facility, citing lack of sterility assurance. This nationwide action, now terminated, underscores critical quality control vulnerabilities in sterile drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply disruptions and patient safety risks.
90-Day Activity
SCA Pharmaceuticals, LLCDextromethorphan Hbr Guaifenesin Phenylephrine Hcl
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2024-04-03