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Recall Observatory FDA recall evidence

Drug product

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.

D-1536-2014

July 02, 2014

Class III

Product summary

Firm
Bracco Diagnostic Inc
Event
Event 68812
Status
Terminated
Classification
Class III
Quantity
216,792 bottles
Official record key
drug-enforcement:D-1536-2014

Official wording

Reason: Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Code information: Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent