CLASS I Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Vecuronium Bromide for Injection, For IV use only recalled
Ben Venue Laboratories is recalling Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, mg Vials, lyophilized, distributed nationwide in the US. The recall was initiated on 26 Jun 2012 and the FDA has classified it as Class I.
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-1697-2012
- FDA event ID
- 62422
- Recalling firm
- Ben Venue Laboratories, Bedford, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Jun 2012
- FDA classified
- 26 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jun 2012 | Recall initiated by company | |
| 26 Sep 2012 | Classified by FDA | +92 days |
| 3 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #2067134 Exp 5/31/2013, NDC 55390-039-10
Where was it sold?
Nationwide
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Ben Venue Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled | Ben Venue Laboratories | Sterility | Nationwide |
| Drug | CLASS I | Acetylcysteine Solution, USP, 10% vial recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection USP, single use vials, 10mg/mL recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Midazolam HCl Injection, 5 mg/mL single use vials recalled | Ben Venue Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Octreotide Acetate Injection, 50 mcg/mL recalled | Ben Venue Laboratories | Packaging Defects | 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 |