Class II · Moderate risk Terminated
E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01
Reason cGMP deviations: Temperature abuse
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
What was recalled
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.
- Recalling firm
- Bracco Diagnostic Inc
- NDC code
- 32909-764-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1536-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Barium recalls
See all
Class II · Moderate risk Terminated
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…
Reason Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class III · Low risk Terminated
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…
Reason Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk Terminated
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary…
Reason Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk Terminated
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…
Reason Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for…
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