CLASS III Drug recall · Reported 19 Feb 2014 · FDA Enforcement Report
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w) recalled
Bracco Diagnostics is recalling VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), distributed nationwide in the US. The recall was initiated on 16 Dec 2013 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-1083-2014
- FDA event ID
- 67262
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Dec 2013
- FDA classified
- 7 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Dec 2013 | Recall initiated by company | |
| 7 Feb 2014 | Classified by FDA | +53 days |
| 19 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Testing: This product is below specification for preservative content.
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
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
Where it was distributed
Nationwide including Puerto Rico
Questions about this recall
Why was it recalled?
Failed Stability Testing: This product is below specification for preservative content.
Which lots are affected?
Lot #: 67603, Expiry: 2/2014
Where was it sold?
Nationwide including 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 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 Bracco Diagnostics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalledE-z-paste | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS III | Tagitol V Barium Sulfate Suspension (40% w/v recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS II | Gastrografin (Diatrizoate Meglumine recalled by Bracco DiagnosticsGastrografin | Bracco Diagnostics | Particulate Matter | Nationwide |
| Drug | CLASS II | Cardiogen-82 (Rubidium Rb 82 Generator), 140 millicurie recalledCardiogen-82 | Bracco Diagnostics | Processing Deviation | Nationwide |
| Drug | CLASS II | Multihance Multipack (gadobenate dimeglumine) injection recalledMultihance | Bracco Diagnostics | Sterility | Nationwide |