Class II · Moderate risk
vecuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Vecuronium bromide for Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Affected NDC
63323-0781-10
Compare with the code on your package — it is the most precise check available.
Drug: Vecuronium
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-781-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0426-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Vecuronium recalls
See all
Class II · Moderate risk
Vecuronium Bromide for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Vecuronium Bromide for Injection 10 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Vecuronium Bromide for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class I · High risk
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Other recalls by Fresenius Kabi USA, LLC
All 2018 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.