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.
Recall Number: D-0929-2017
Firm: Allergan Sales, LLC
Classification: Class II
Status: Terminated
Report Date: 20170705
Initiation Date: 20170501
Termination Date: 20190501
Reason for Recall
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Product Description
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.