CLASS III Drug recall · Reported 1 Jul 2015 · FDA Enforcement Report
E-z-cat Dry Barium Sulfate for Suspension (2% w/w after mixing) recalled
Bracco Diagnostic is recalling E-z-cat Dry Barium Sulfate for Suspension (2% w/w after mixing), distributed nationwide in the US. The recall was initiated on 27 May 2015 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-1147-2015
- FDA event ID
- 71442
- Recalling firm
- Bracco Diagnostic, Monroe Township, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 May 2015
- FDA classified
- 22 Jun 2015
- Reported
- 1 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 27 May 2015 | Recall initiated by company | |
| 22 Jun 2015 | Classified by FDA | +26 days |
| 1 Jul 2015 | Published in enforcement report | +9 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:This recall has been initiated due to out of specification results 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
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Which lots are affected?
Lot #: 00513716, 00514712, Exp 03/2016
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 Diagnostic
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | E-z- Gas II Effervescent Granules Antacid/Antiflatulent recalledE-z-gas | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS III | E-z-hd (barium sulfate) For Suspension (98% w/w) recalledE-z-hd | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS I | Isovue -300 (Iopamidol) Injection 61% Prefilled recalled | Bracco Diagnostic | Particulate Matter | Nationwide |
| Drug | CLASS I | Isovue -370 (Iopamidol) Injection 76%, Prefilled mL recalled | Bracco Diagnostic | Particulate Matter | Nationwide |
| Drug | CLASS III | Choletec - Kit for the Preparation of Technetium Tc 99m recalledCholetec | Bracco Diagnostic | Particulate Matter | Nationwide |