E-Z-EM Canada Inc
NDC labeler code: 32909
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Barium sulfateE-Z-Paque, Readi-Cat 2, Varibar Nectar · 15 products
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 14, 2016 | NDA208844 | Barium sulfate VARIBAR PUDDING | Bracco |
| January 15, 2016 | NDA208143 | Barium sulfate ENTERO VU 24%, LIQUID E-Z-PAQUE, READI-CAT 2 | Bracco |
| January 11, 2016 | NDA208036 | Barium sulfate E-Z-CAT DRY, E-Z-HD, E-Z-PAQUE | Bracco |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
April 13, 2022 · Class II · Terminated · D-1084-2022 · Barium sulfate
cGMP deviations: Temperature abuse
E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01
2014
-
July 2, 2014 · Class III · Terminated · D-1536-2014 · Barium sulfate
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
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.
2013
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July 19, 2013 · Class III · Terminated · D-914-2013 · Barium sulfate
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
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 1-800-54
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026