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Somerset Therapeutics LLC FDA Recalls
6 recalls on file across drugs, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, ManufacClass IIFeb 4, 2026Failed Impurities/Degradation Specifications - OOS impuritie |
| Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, ManufaClass IIINov 26, 2025Subpotent product:out of specification assay results observe |
| Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, ManufactureClass IIINov 26, 2025Subpotent product:out of specification assay results observe |
| Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, ManufacturClass IIINov 26, 2025Subpotent product:out of specification assay results observe |
| Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. SomerClass IIIDec 16, 2024Failed Impurities/Degradation Specifications |
| Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-DClass IIApr 24, 2024Presence of Foreign Substance: This oil based product may co |