Reported Jul 5, 2017 · Terminated
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX…
Allergan Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergan Sales, LLC · 8301 Mars Dr · Waco, TX · 76712-6578
Is this the product you have?
- 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
- NDC0023-0313-04
- Lot codes and dates
- Lot
93802EXP NOV 2019
- Lot
- Amount recalled
- 648 units
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
This product could cause temporary or reversible health problems — stop using it.
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