D-1536-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2014
- Initiation Date
- July 2, 2014
- Termination Date
- June 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216,792 bottles
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15