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.

FDA recall notice · announced July 5, 2017 · Allergan Sales

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot: 93802, EXP NOV 2019
Quantity: 648 units
Status: Terminated
Products in this recall event:
- 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 (D-0929-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.