Class II · Moderate risk Ongoing
prednisoLONE Acetate Ophthalmic Suspension
Reason Presence of Foreign Substance
Blephamide
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
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.
- Recalling firm
- Allergan Sales, LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0929-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Prednisolone recalls
See all
Class III · Low risk Ongoing
Pred Mild
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
methylprednisolone tablets
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
MethylPREDNISolone Acetate Injectable Suspension
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
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