Drug recall
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only…
FDA recall event 94528 · Class III · Hikma Injectables USA Inc
Key facts
| Event ID | 94528 |
|---|---|
| Recall numbers | D-0480-2024 |
| Recalling firm | Hikma Injectables USA Inc |
| Product type | Drugs |
| Products | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed… |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Wrong Barcode |
| Initiation date | Apr 30, 2024 |
| Report date | May 8, 2024 |
| City | Dayton |
| State | NJ |
| Country | United States |
| FEI number | 3022897129 |
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: