Food, drugs, devices › Bracco Diagnostic Inc
Drug recall: E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiar
Bracco Diagnostic Inc (Monroe Township, NJ) initiated this drug recall on 2 Jul 2014; FDA lists 1 product record under event 68812, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 30 Jun 2015. Initiation: voluntary: firm initiated. Bracco Diagnostic Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bracco Diagnostic Inc, Monroe Township, NJ.
Reason for recall
"Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months."
Distribution
"Nationwide and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1536-2014 | 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. | 216,792 bottles | Class III | Terminated | 20 Aug 2014 |
Context
Other enforcement events for Bracco Diagnostic Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 May 2015 | E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Cana | Drug | Class III | 1 |
| 18 Sep 2014 | E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for | Drug | Class III | 1 |
| 21 Nov 2012 | Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 | Drug | Class I | 2 |
| 14 Aug 2012 | Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, Fo | Drug | Class III | 1 |
All 5 events for Bracco Diagnostic Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.