Reported Dec 24, 2025 · Ongoing
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only,…
Somerset Therapeutics LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SOMERSET THERAPEUTICS LLC · 300 Franklin Square Dr · Somerset, NJ · 08873-4187
Is this the product you have?
Cisatracurium Besylate Injection USP20 mg/10 mL*(2 mg/mL)10 x 10 mL Multiple-dose Vials per cartonRx Only
- Manufactured forSomerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01
- Lot codes and dates
Lot#: A250043EXP Date 06/30/2026
- Amount recalled
- 71,310 10mL vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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