Cipla USA Initiates Nationwide Recall of Lanreotide Injection Over Sterility Concerns at Contract Manufacturer Pharmathen
Cipla USA, Inc. has initiated a Class II nationwide recall of multiple lots of Lanreotide Injection, 120 mg/0.5 mL, due to a lack of sterility assurance. This critical regulatory action stems from FDA observations at its contract manufacturer, Pharmathen International, S.A., highlighting deficiencies in visual inspection procedures. This impacts supply and demands immediate attention from procurement and regulatory teams.