RecallRadar

FDA Drug recall 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.,…

On 2014-08-20 the FDA classified a Class III recall of 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.,… by Bracco Diagnostic, citing subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1536-2014
ClassificationClass III
Statusterminated
Initiated2014-07-02
Published2014-08-20
Last updated2026-09-13 11:51 UTC
CompanyBracco Diagnostic
DistributionUS

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.

Reason

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

Identifiers

ndc32909-764-01
code_infoLot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1536-2014%22

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