Drug recall
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma…
FDA recall event 94522 · Class I · Hikma Injectables USA Inc
Key facts
| Event ID | 94522 |
|---|---|
| Recall numbers | D-0508-2024 |
| Recalling firm | Hikma Injectables USA Inc |
| Product type | Drugs |
| Products | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25 |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. |
| Initiation date | Apr 29, 2024 |
| Report date | May 29, 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: