CLASS III Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Tagitol V Barium Sulfate Suspension (40% w/v recalled
Bracco Diagnostics is recalling Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents:, (, distributed nationwide in the US. The recall was initiated on 19 Jul 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-914-2013
- FDA event ID
- 66032
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jul 2013
- FDA classified
- 22 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Jul 2013 | Recall initiated by company | |
| 22 Aug 2013 | Classified by FDA | +34 days |
| 28 Aug 2013 | Published in enforcement report | +6 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 Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
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
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Which lots are affected?
Lot #65846
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 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 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w) 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 |