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.

FDA recall notice · announced August 20, 2014 · Bracco Diagnostic

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
Quantity: 216,792 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.