Somerset Therapeutics recalls 10x5mL cisatracurium besylate injection vials due to subpotent product from assay results during stability testing. This may affect medical use safety.
Subpotent product:out of specification assay results observed during long term stability testing.
Somerset Therapeutics has recalled certain cisatracurium besylate injection vials because lab tests showed the product is less potent than it should be. This could lead to ineffective medical treatment if used as intended.
The product was found to be less potent than specified during long-term stability testing. This means it may not work effectively when administered, potentially leading to inadequate anesthesia effects during surgery.
Healthcare professionals who use this medication for anesthesia. Patients receiving this drug during surgery are at risk if the product is used without proper potency.
Check for vials labeled 'Cisatracurium Besylate Injection USP, 10 mg/5 mL (2mg/mL), 10 x 5 mL Single-dose Vials per Carton' with NDC numbers 70069-141-01 or 70069-141-10. The lot numbers A240438 (expiring 1/31/26) or A250125 (expiring 8/31/26) are also indicators.
Verify the NDC numbers and lot numbers listed in the recall notice to confirm if your vials are affected.
The product was found to be less potent than specified during long-term stability testing, which could lead to ineffective medical treatment.
Check the NDC numbers and lot numbers to confirm if your vials are affected; contact Somerset Therapeutics for further instructions.
The recall indicates a potential risk of reduced potency, but the product is not unsafe to use if it has been properly tested and stored.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0236-2026 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0236-2026 from Somerset Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
