Recalls / Class III
Class IIID-1536-2014
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.
- Brand name
- E-z-hd
- Generic name
- Barium Sulfate
- Active ingredient
- Barium Sulfate
- Route
- Oral
- NDC
- 32909-764
- FDA application
- NDA208036
- Affected lot / code info
- Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
Why it was recalled
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Recalling firm
- Firm
- Bracco Diagnostic Inc
- Manufacturer
- E-Z-EM Canada Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Road, Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 216,792 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-07-02
- FDA classified
- 2014-08-12
- Posted by FDA
- 2014-08-20
- Terminated
- 2015-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1536-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.