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.
Reported: December 24, 2025 Initiated: November 26, 2025 #D-0236-2026
Product Description
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 for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Details
- Recalling Firm
- SOMERSET THERAPEUTICS LLC
- Units Affected
- 52,340 5mL vials
- Distribution
- Nationwide in the USA
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SOMERSET THERAPEUTICS LLC. Units affected: 52,340 5mL vials.
Why was this product recalled? ▼
Subpotent product:out of specification assay results observed during long term stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2025. Severity: Low. Recall number: D-0236-2026.
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