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-do
Somerset Therapeutics is recalling Cisatracurium Besylate Injection (a muscle relaxant medication) nationwide because testing found the drug contains less active ingredient than specified on the label. The affected product is sold in single 5 mL vials and 10-pack cartons with specific NDC numbers. This is a Class I recall, the most serious classification, affecting all 50 states and Washington, D.C.
- Recalling firm
- 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
- Subpotent product:out of specification assay results observed during long term stability testing.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-26
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/6a7dce1a-edcc-450c-bb35-c4c052f36390