Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | Cherry Hill, NJ, United States | Makes it, tests it, packages it and labels it | No problems foundMay 13, 2026 · 18 inspections |
Recalls
- Dec 7, 2020 · Class II · Hikma Pharmaceuticals USA Inc.
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Lots: Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022. - Nov 3, 2020 · Class II · Hikma Pharmaceuticals USA Inc.
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Lots: a) Vial Lot #s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/2023; b) Carton Lot #: 068322, Exp. 06/2021.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, intramuscular; intravenous; subcutaneous
- Strength
- 9 mg per 1 mL
- Approval
- ANDA ANDA201833
- On the market since
- Sep 24, 2013
- Package NDCs
0641-0497-170641-0497-25- Official label
- DailyMed (National Library of Medicine), updated Apr 10, 2024
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