Class II · Moderate risk
vecuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
VECURONIUM Bromide for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
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* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
Affected NDC
25021-0657-10
Compare with the code on your package — it is the most precise check available.
Drug: Vecuronium
- Recalling firm
- Sagent Pharmaceuticals Inc
- NDC code
- 25021-657-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-605-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Sagent Pharmaceuticals Inc
All 2013 recalls
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
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