NDC 70069-025
Dexamethasone Sodium Phosphate 10 mg per 1 mL injection, solution
On the label: Somerset Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Feb 4, 2026 · Class II · Somerset Therapeutics Llc
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Lots: Lot #: A240421, Exp 07/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dexamethasone: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA211036
- On the market since
- Jun 11, 2019
- Package NDCs
70069-025-10- Official label
- DailyMed (National Library of Medicine), updated Feb 14, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?