Product: Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Reason for recall: Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Recall initiated: 20170501
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated