Somerset Therapeutics recalls 10x10mL Cisatracurium Besylate Injection vials due to subpotent product from stability testing. Affected lots may not be effective for medical use.
Subpotent product:out of specification assay results observed during long term stability testing.
Somerset Therapeutics is recalling certain Cisatracurium Besylate Injection vials because lab tests showed the product is less potent than it should be. This means the medication might not work properly when used as intended.
The product failed stability testing, meaning it may not have the correct potency over time. This could lead to the medication being less effective during anesthesia procedures.
Healthcare professionals who use this medication for anesthesia. Patients receiving this drug during surgery are at risk if the product is not effective.
Check for the product name 'Cisatracurium Besylate Injection USP, 20 mg/10 mL', 10 vials per carton, NDC 70069-161-01, and lot number A250043 with expiration date 06/30/2026.
Verify the product name, NDC 70069-161-01, and lot number A250043 on the vial packaging.
The product may be less potent than expected, so it should not be used without confirming effectiveness through testing.
Check the product details and contact Somerset Therapeutics for guidance on whether to use or return the product.
Look for NDC 70069-161-01, lot number A250043, and expiration date 06/30/2026 on the vial packaging.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0238-2026 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0238-2026 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.