[pending] DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
Pending LLM rewrite. Source: FDA_DRUG D-0398-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: A240421
- Exp 07/31/2026
UPCs (2)
- 0370069025109
- 0370069025017
Distribution
Distributed nationwide across the United States.
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