Drug recall
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only…
FDA recall event 80354 · Class II · Advanced Pharma Inc.
Key facts
| Event ID | 80354 |
|---|---|
| Recall numbers | D-0889-2018 |
| Recalling firm | Advanced Pharma Inc. |
| Product type | Drugs |
| Products | fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. |
| Initiation date | Jun 20, 2018 |
| Report date | Jul 4, 2018 |
| Termination date | Apr 3, 2019 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3005247494 |
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: