Drug recall
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g…
FDA recall event 77143 · Class II · Allergan Sales, LLC
Key facts
| Event ID | 77143 |
|---|---|
| Recall numbers | D-0929-2017 |
| Recalling firm | Allergan Sales, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. |
| Initiation date | May 1, 2017 |
| Report date | Jul 5, 2017 |
| Termination date | May 1, 2019 |
| City | Waco |
| State | TX |
| Country | United States |
| FEI number | 1643525 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: