Drug recall
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use…
FDA recall event 92737 · Class II · SCA Pharmaceuticals
Key facts
| Event ID | 92737 |
|---|---|
| Recall numbers | D-0945-2023 |
| Recalling firm | SCA Pharmaceuticals |
| Product type | Drugs |
| Products | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP deviations: due to shipment of rejected units. |
| Initiation date | Jul 20, 2023 |
| Report date | Aug 2, 2023 |
| Termination date | Sep 21, 2023 |
| City | Windsor |
| State | CT |
| Country | United States |
| FEI number | 3013736415 |
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: