Why it was recalled
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Product description
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
Lot numbers, UPCs & expiration codes
Lot #65846
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-914-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 19, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 3,096 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-914-2013, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66032
- Address
- 259 Prospect Plains Rd.
- Address (line 2)
- Building H
- Code information
- Lot #65846
- Postal code
- 08831
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-914-2013
- Classification
- Class III
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 3,096 bottles
- Termination date
- Jan 29, 2015
- Reason for recall
- Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2013