SOMERSET THERAPEUTICS LLC: Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Ther
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- SOMERSET THERAPEUTICS LLC
- Product
- Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
- Reason / hazard
- Subpotent product:out of specification assay results observed during long term stability testing.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2025-11-26
- Code info
- Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
- Product quantity
- 52,340 5mL vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Somerset
- State
- NJ
- Country
- United States
- Event id
- 98063
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