Cisatracurium Besylate Injection Usp, 20 Mg/10 Ml*,(2 Mg/ml), 10 X 10 Ml Multiple-dose Vials Per Carton, Rx Only, Manufactured For: Somerset Therapeutics, Llc, Hollywood, Fl 33024, Made In India, 10ml
Recall Summary Somerset Therapeutics is recalling Cisatracurium Besylate Injection (a muscle relaxant medication used during surgery) distributed nationwide because stability testing found the drug contains less active ingredient than required. This is a serious recall affecting all 50 states and Washington, D.C.
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product
- Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
- 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/d1509de1-59eb-4799-8089-7b441bb5998d