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.
Reported: July 5, 2017 Initiated: May 1, 2017 #D-0929-2017
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Details
- Recalling Firm
- Allergan Sales, LLC
- Units Affected
- 648 units
- Distribution
- Nationwide in the US
- Location
- Waco, TX
Frequently Asked Questions
What product 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.. Recalled by Allergan Sales, LLC. Units affected: 648 units.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 5, 2017. Severity: Moderate. Recall number: D-0929-2017.
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