FDA Drug Class II — Moderate

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.

Hazard

Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.

Products

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: 0023-0313-0
Brand
Allergan Sales, LLC
UPC
Lot: 93802, EXP NOV 2019

Units Affected

648 units