Somerset Therapeutics LLC is recalling 152,310 vials of Cisatracurium Besylate Injection USP due to subpotency. Long-term stability testing revealed that the drug's potency fell below required specifications, meaning the medication may not work as effectively as intended. The recall affects multiple strengths and sizes, including 10 mg/5 mL, 20 mg/10 mL, and 200 mg/20 mL vials distributed nationwide across the United States.
Subpotent medication may lead to inadequate neuromuscular blockade in patients during surgery or while on a ventilator, potentially causing medical complications due to the drug not performing at its full strength. No incidents or injuries have been reported to date.
10 x 5 mL Single-dose Vials per Carton; Made in India
10 x 20 mL Single-dose Vials per Carton; Made in India
10 x 10 mL Multiple-dose Vials per Carton; Made in India
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Sources: FDA iRES · Raw API Response
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