CLASS II Drug recall · Reported 20 Apr 2016 · FDA Enforcement Report
Cisatracurium Besylate Injection, 20 mg per (2 mg per mL) recalled
Fresenius Kabi USA is recalling Cisatracurium Besylate Injection, 20 mg per (2 mg per mL), For intravenous injection, distributed nationwide in the US. The recall was initiated on 5 Apr 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0819-2016
- FDA event ID
- 73751
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Cisatracurium
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2016
- FDA classified
- 12 Apr 2016
- Reported
- 20 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Apr 2016 | Recall initiated by company | |
| 12 Apr 2016 | Classified by FDA | +7 days |
| 20 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 6010157, Exp. 01/2017
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Cisatracurium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS I | Cisatracurium Besylate Injection, USP, 10mg recalledCisatracurium Besylate | Meitheal Pharmaceuticals | Labeling Errors | Nationwide |