FDAMay 1, 2017drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

allergan salesallergan

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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