FDA DrugsClass II
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 ...
Published: March 25, 2026Recall ID: D-0398-2026Category: drugsCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Additional Source Details
| Field | Value |
|---|---|
| City | Somerset |
| State | NJ |
| Openfda › Upc › 1 | 0370069025109 |
| Openfda › Upc › 2 | 0370069025017 |
| Openfda › Unii | AI9376Y64P |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Rxcui | 309696 |
| Openfda › Spl id | 0fefe630-0e29-4d04-a083-eb3036f48100 |
| Openfda › Brand name | DEXAMETHASONE SODIUM PHOSPHATE |
| Openfda › Spl set id | 5a1b0266-90c8-4176-a6b0-c4204d3c604e |
| Openfda › Package ndc › 1 | 70069-025-10 |
| Openfda › Package ndc › 2 | 70069-025-01 |
| Openfda › Product ndc | 70069-025 |
| Openfda › Generic name | DEXAMETHASONE SODIUM PHOSPHATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DEXAMETHASONE SODIUM PHOSPHATE |
| Openfda › Manufacturer name | Somerset Therapeutics, LLC |
| Openfda › Application number | ANDA211036 |
| Openfda › Is original packager | true |
| Event id | 98388 |
| Address 1 | 300 Franklin Square Dr |
| Address 2 | N/A |
| Code info | Lot #: A240421, Exp 07/31/2026 |
| Postal code | 08873-4187 |
| Report date | 20260325 |
| Product type | Drugs |
| Product quantity | 62190 vials |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260204 |
| Initial firm notification | Letter |
| Center classification date | 20260318 |
Overview
- Recalling FirmSOMERSET THERAPEUTICS LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA