Cisatracurium Besylate Recall: Somerset Therapeutics
The recall concerns Cisatracurium Besylate Injection USP 10 mg/5 mL single-dose vials (Rx Only) manufactured for Somerset Therapeutics and distributed nationwide. The product was found subpotent based on out of specification assay results observed during long term stability testing. About 52,340 vials were distributed nationwide; affected lots are A240438 (Exp 1/31/26) and A250125 (Exp 8/31/26).
| 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 | Subpotent product:out of specification assay results observed during long term stability testing. |
| Severity | low |
| Units affected | 62190 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any lots A240438 or A250125.
- Quarantine and return or dispose of affected vials according to supplier or manufacturer instructions.
- Consult with your healthcare provider or facility for replacement options and guidance.
- For questions, contact Somerset Therapeutics or the FDA recall contact.
How to identify the recalled item
| Lot / date codes | Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26 |
|---|---|
| Lot / date codes | Lot #: A240421, Exp 07/31/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.