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.
Reported: September 30, 2015 Initiated: August 24, 2015 #D-1820-2015
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Allergan Sales, LLC
- Units Affected
- 337 tubes
- Distribution
- Nationwide, Puerto Rico, and Barbados
- Location
- Waco, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Allergan Sales, LLC. Units affected: 337 tubes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 30, 2015. Severity: Moderate. Recall number: D-1820-2015.
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