FDA Class I Recall: SCA Pharmaceuticals' Heparin Sodium Contained Undeclared Benzyl Alcohol, Highlighting Critical Quality Control Gaps
SCA Pharmaceuticals initiated a Class I recall for 362 containers of Heparin Sodium 10,000 units/mL due to undeclared benzyl alcohol, mislabeled as parabens. This event, terminated in May 2021, underscores critical quality control and labeling deficiencies, posing significant risks for procurement and regulatory teams managing pharmaceutical supply chain integrity and patient safety.