Allergan Sales, LLC recalls Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX on…
- Recall date
- May 1, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0929-2017
- FDA classification
- Class II
- Brand / firm
- Allergan Sales, LLC
- Sold / distributed
- Nationwide in the US
Why it was recalled
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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