Somerset Therapeutics recalls cisatracurium besylate injection vials with subpotent product due to assay results during stability testing. No specific remedy provided in the recall notice.
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 affect medical safety during anesthesia procedures.
The product was found to be less potent than specified during long-term stability testing. This means it may not work effectively during anesthesia, potentially leading to inadequate muscle relaxation.
Healthcare providers who use this medication for anesthesia procedures. 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, 200mg/20mL (10mg/mL), 10 x 20 mL Single-dose Vials per Carton' with NDC 70069-151-01 or 70069-151-10. The lot number A250020 was produced in India and expires June 30, 2026.
Look for the NDC numbers 70069-151-01 or 70069-151-10 on the vial packaging.
The recall indicates the product may be less potent than specified, so it should not be used until the remedy is confirmed.
The recall notice does not specify a remedy, so providers should check with Somerset Therapeutics for guidance.
Check for vials with NDC 70069-151-01 or 70069-151-10, lot number A250020, and expiration date June 30, 2026.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0237-2026 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0237-2026 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.
