Class III · Low risk Ongoing
Cisatracurium Besylate Injection USP
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Cisatracurium Besylate Injection USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
What was recalled
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
- Recalling firm
- Somerset Therapeutics LLC
- NDC code
- 70069-141-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0236-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cisatracurium recalls
See all
Class III · Low risk Ongoing
Cisatracurium Besylate Injection USP
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Class I · High risk Terminated
Cisatracurium Besylate Injection
Reason Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Class II · Moderate risk Terminated
Cisatracurium Besylate Injection
Reason Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk Terminated
Cisatracurium Besylate active pharmaceutical ingredient packaged…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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