FDAAugust 24, 2015drug

BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.

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

The hazard

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

What to do

FDA enforcement status: Terminated

Brands named

allergan salesallergan

UPCs

300230313049

Recall history

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

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