Drug recall
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV, Compounded by: Premier Pharmacy Labs 8265…
FDA recall event 78928 · Class II · Premier Pharmacy Labs Inc
Key facts
| Event ID | 78928 |
|---|---|
| Recall numbers | D-0251-2018 |
| Recalling firm | Premier Pharmacy Labs Inc |
| Product type | Drugs |
| Products | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Error on Declared Strength |
| Initiation date | Jan 11, 2018 |
| Report date | Feb 7, 2018 |
| Termination date | Jun 4, 2020 |
| City | Weeki Wachee |
| State | FL |
| Country | United States |
| FEI number | 3007271263 |
At a glance
- 1–9 Products in this recall
- 1–9 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: