Class II · Moderate risk
vecuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Vecuronium Bromide for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
55390-0039-10
Compare with the code on your package — it is the most precise check available.
Drug: Vecuronium
- Recalling firm
- Ben Venue Laboratories Inc
- NDC code
- 55390-039-10
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1697-2012 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Ben Venue Laboratories Inc
All 2012 recalls
Class II · Moderate risk
CYTARAbine for Injection USP
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Class I · High risk
Acetylcysteine Solution
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Class II · Moderate risk
Leucovorin Calcium Injection USP
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class II · Moderate risk
Octreotide Acetate Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
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