CLASS II Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalled
Bracco Diagnostics is recalling E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube, distributed nationwide in the US. The recall was initiated on 8 Mar 2018 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-0609-2018
- FDA event ID
- 79481
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Brand
- E-z-paste
- Manufacturer
- E-Z-EM Canada Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2018
- FDA classified
- 29 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 8 Mar 2018 | Recall initiated by company | |
| 29 Mar 2018 | Classified by FDA | +21 days |
| 4 Apr 2018 | 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: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
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
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Where it was distributed
Product was distributed throughout the United States, Hong Kong and New Zealand.
Questions about this recall
Is E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalled?
Yes. Bracco Diagnostics recalled E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube on 8 Mar 2018. The recall is Class II and its status is Terminated. Recall number D-0609-2018.
Why was it recalled?
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Which lots are affected?
Lot # 00538529
Where was it sold?
Product was distributed throughout the United States, Hong Kong and New Zealand.
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 Bracco Diagnostics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | VoLumen Barium Sulfate Suspension 1 % w/v, 1 ww/w) recalled | 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 | Sterility | Nationwide |
| Drug | CLASS II | Multihance Multipack (gadobenate dimeglumine) injection recalledMultihance | Bracco Diagnostics | Sterility | Nationwide |
Other Barium recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | E-z-hd (Barium Sulfate for Oral Suspension), 98% w/w recalledE-z-hd | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | E-z-hd (barium sulfate) For Suspension (98% w/w) recalledE-z-hd | Bracco Diagnostic | Potency & Assay | Nationwide |