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.