FDA-Drug2015-09-30Class II
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.
Allergan Sales, LLC
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.
Sold states
Nationwide, Puerto Rico, and Barbados
Affected count
337 tubes
Manufactured in
8301 Mars Dr, N/A, Waco, TX, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1820-2015Don't want to check this manually?
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