FDA-Drug2017-07-05Class II

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.

Allergan Sales, LLC
Hazard

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

Sold states
Nationwide in the US
Affected count
648 units
Manufactured in
8301 Mars Dr, N/A, Waco, TX, United States
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: 0023-0313-04.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0929-2017

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