Cisatracurium Besylate Injection Usp, 200mg/20ml*(10mg/ml), 10 X 20 Ml Single-dose Vials Per Carton, Rx Only, Manufactured For: Somerset Therapeutics, Llc, Hollywood, Fl 33024, Made In India, Single D
Recall Summary Cisatracurium Besylate Injection (a medication used during anesthesia) manufactured by Somerset Therapeutics is being recalled nationwide because testing found the product contains less active ingredient than specified. The affected products are single-dose vials with NDC numbers 70069-151-01 and 70069-151-10, distributed across all U.S. states.
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product
- Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
- 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/bc20d85c-41d8-4026-86c2-5364279b0beb