Dexamethasone injection failed impurity specifications at product expiry testing
Somerset Therapeutics is recalling one lot of Dexamethasone Sodium Phosphate Injection after out-of-specification impurity results at product expiry during long term stability testing.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the injectable medicine failed named impurity specifications rather than an appearance test, and no injuries are stated.
Plain-English summary
Somerset Therapeutics LLC is recalling Dexamethasone Sodium Phosphate Injection USP, 100 mg/10 mL (10 mg/mL), in 10 x 10 mL multiple dose vials, prescription only, NDC carton 70069-025-10 and NDC vial 70069-025-01. About 62,190 vials were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for failed impurities and degradation specifications. Out-of-specification impurity results were observed during long term stability testing at product expiry, at 24 months, above specification for Dexamethasone Sodium Phosphate EP impurity G (impurity RU 49336) and dexamethasone formate.
Affected product is lot A240421 with an expiry date of 07/31/2026.
Clinicians and pharmacies can identify affected product by the NDC and lot number above, and may contact Somerset Therapeutics LLC for further information.
The recalled product
- Product
- DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Category
- Drug — Injectable
- Affected units
- 62,190
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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