Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Recall Number: D-1581-2015
Firm: The Compounding Pharmacy of America
Classification: Class II
Status: Terminated
Report Date: 20150923
Initiation Date: 20150602
Termination Date: 20160210
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product Description
Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN