Product: 5-Fluorouracil 1% ophthal
Reason for recall: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: 20131101
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated