Drugplain

Cisatracurium 10 mg/mL

CISATRACURIUM BESYLATE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC

6 Recalls on RecordCurrently in Shortage
Plain English

Cisatracurium is a injection, solution containing cisatracurium besylate at 10 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.

Key Facts

Brand Name
Cisatracurium
Generic Name
CISATRACURIUM BESYLATE
NDC Code (Product)
63323-418
Manufacturer
Fresenius Kabi USA, LLC
Strength
10 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA203182
Marketing Start
02/26/2015

Recall History

6 Recalls on Record
Class III11/26/2025

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

OngoingVoluntary: Firm initiated
Class III11/26/2025

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

OngoingVoluntary: Firm initiated
Class II04/05/2016

Fresenius Kabi USA, LLC

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.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

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.

TerminatedVoluntary: Firm initiated
Class III11/26/2025

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

OngoingVoluntary: Firm initiated
Class I01/27/2021

Meitheal Pharmaceuticals Inc

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

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Cisatracurium used for?

Cisatracurium contains CISATRACURIUM BESYLATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Cisatracurium a controlled substance?

Cisatracurium is not classified as a controlled substance by the DEA.

What is the generic name for Cisatracurium?

The generic name for Cisatracurium is CISATRACURIUM BESYLATE. There are 11 other brand versions of CISATRACURIUM BESYLATE.

What is the NDC code for Cisatracurium 10 mg/mL?

The NDC (National Drug Code) for Cisatracurium 10 mg/mL is 63323-418, listed by Fresenius Kabi USA, LLC.