Drug recall
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a…
FDA recall event 86685 · Class II · Hikma Pharmaceuticals USA Inc.
Key facts
| Event ID | 86685 |
|---|---|
| Recall numbers | D-0101-2021 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Product type | Drugs |
| Products | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. |
| Initiation date | Nov 3, 2020 |
| Report date | Nov 25, 2020 |
| Termination date | Nov 17, 2022 |
| 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: