CLASS II Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
Vecuronium Bromide for Injection, 10 mg* per vial recalled
Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to, distributed nationwide in the US. The recall was initiated on 7 Jun 2013 and the FDA has classified it as Class II.
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-605-2013
- FDA event ID
- 65339
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2013
- FDA classified
- 18 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Jun 2013 | Recall initiated by company | |
| 18 Jun 2013 | Classified by FDA | +11 days |
| 26 Jun 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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* 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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Vecuronium Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to recalled?
Yes. Sagent Pharmaceuticals recalled Vecuronium Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to on 7 Jun 2013. The recall is Class II and its status is Terminated. Recall number D-605-2013.
Why was it 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.
Which lots are affected?
Lot #s: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A, Exp 07/13; 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A, Exp 09/13; 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, Exp 10/13; 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A, Exp 11/13; 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A, Exp 12/13; 12A02161A, Exp 01/14; 12B04871A, 12B04921A, 12B06501A, 12B06741A, Exp 02/14; 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A, Exp 03/14; 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A, Exp 04/14; 12E15981A, Exp 05/14
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Vecuronium bromide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg recalled | Teva Pharmaceuticals U | 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 |