Why it was recalled
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Product description
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
Lot numbers, UPCs & expiration codes
Lot #: 00513716, 00514712, Exp 03/2016
Where it was sold
Nationwide
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-1147-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 27, 2015
- FDA report date
- Jul 1, 2015
- Quantity
- 1008 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostic Inc
Original FDA data
Every field from FDA enforcement report D-1147-2015, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71442
- Address
- 259 Prospect Plains Road
- Address (line 2)
- Building H
- Code information
- Lot #: 00513716, 00514712, Exp 03/2016
- Postal code
- 08831
- Report date
- Jul 1, 2015
- Product type
- Drugs
- Recall number
- D-1147-2015
- Classification
- Class III
- Recalling firm
- Bracco Diagnostic Inc
- Product quantity
- 1008 boxes
- Termination date
- Feb 19, 2016
- Reason for recall
- Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
- Distribution pattern
- Nationwide
- Recall initiation date
- May 27, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 22, 2015