Why it was recalled
Failed Stability Testing: This product is below specification for preservative content.
Product description
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
Lot numbers, UPCs & expiration codes
Lot #: 67603, Expiry: 2/2014
Where it was sold
Nationwide including 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-1083-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 16, 2013
- FDA report date
- Feb 19, 2014
- Quantity
- 54,648 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-1083-2014, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67262
- Address
- 259 Prospect Plains Rd.
- Address (line 2)
- Building H
- Code information
- Lot #: 67603, Expiry: 2/2014
- Postal code
- 08831
- Report date
- Feb 19, 2014
- Product type
- Drugs
- Recall number
- D-1083-2014
- Classification
- Class III
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 54,648 bottles
- Termination date
- Jan 23, 2015
- Reason for recall
- Failed Stability Testing: This product is below specification for preservative content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Dec 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2014