CLASS III Drug recall · Reported 20 Aug 2014 · FDA Enforcement Report
E-z-hd (barium sulfate) For Suspension (98% w/w) recalled
Bracco Diagnostic is recalling E-z-hd (barium sulfate) For Suspension (98% w/w), distributed nationwide in the US. The recall was initiated on 2 Jul 2014 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-1536-2014
- FDA event ID
- 68812
- Recalling firm
- Bracco Diagnostic, Monroe Township, NJ
- Brand
- E-z-hd
- Manufacturer
- E-Z-EM Canada Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Jul 2014
- FDA classified
- 12 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Jul 2014 | Recall initiated by company | |
| 12 Aug 2014 | Classified by FDA | +41 days |
| 20 Aug 2014 | 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
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
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-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Which lots are affected?
Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
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 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-cat Dry Barium Sulfate for Suspension (2% w/w after mixing) recalled | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS III | E-z- Gas II Effervescent Granules Antacid/Antiflatulent recalledE-z-gas | 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 |
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 II | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalledE-z-paste | Bracco Diagnostics | Potency & Assay | Nationwide |