Drug recall
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA…
FDA recall event 84676 · Class III · Hikma Pharmaceuticals USA Inc.
Key facts
| Event ID | 84676 |
|---|---|
| Recall numbers | D-0801-2020 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Product type | Drugs |
| Products | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for… |
| Initiation date | Jan 14, 2020 |
| Report date | Jan 29, 2020 |
| Termination date | Sep 8, 2021 |
| City | Cherry Hill |
| State | NJ |
| Country | United States |
| FEI number | 2220525 |
At a glance
- 1–9 Products in this recall
- 10–99 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: