Recalls / Class III
Class IIID-914-2013
Product
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
- Brand name
- Tagitol V
- Generic name
- Barium Sulfate
- Active ingredient
- Barium Sulfate
- Route
- Oral
- NDC
- 32909-814
- FDA application
- NDA208143
- Affected lot / code info
- Lot #65846
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.
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Manufacturer
- E-Z-EM Canada Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd., Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 3,096 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-19
- FDA classified
- 2013-08-22
- Posted by FDA
- 2013-08-28
- Terminated
- 2015-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-914-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.