CLASS III Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Vecuronium bromide for Injection, 10 mg vials recalled
Fresenius Kabi USA is recalling Vecuronium bromide for Injection, 10 mg vials, distributed nationwide in the US. The recall was initiated on 16 Jan 2018 and the FDA has classified it as Class III.
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-0426-2018
- FDA event ID
- 78949
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jan 2018
- FDA classified
- 15 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Jan 2018 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +22 days |
| 15 Feb 2018 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Which lots are affected?
Lot #: ZG603, Exp 11/18
Where was it sold?
Nationwide USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Vecuronium recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | vecuronium, 10 mg/, (1 mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection 20 mg* *1mg/mL when recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection 10 mg* recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |