Why it was recalled
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
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.
Lot numbers, UPCs & expiration codes
Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1536-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 2, 2014
- FDA report date
- Aug 20, 2014
- Quantity
- 216,792 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostic Inc
Original FDA data
Every field from FDA enforcement report D-1536-2014, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68812
- Address
- 259 Prospect Plains Road
- Address (line 2)
- Building H
- Code information
- Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
- Postal code
- 08831
- Report date
- Aug 20, 2014
- Product type
- Drugs
- Recall number
- D-1536-2014
- Classification
- Class III
- Recalling firm
- Bracco Diagnostic Inc
- Product quantity
- 216,792 bottles
- Termination date
- Jun 30, 2015
- Reason for recall
- Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 2, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2014