Status
Terminated
Drug Enforcement D-914-2013
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Classification
Class III
Report Date
August 28, 2013
Termination Date
January 29, 2015
Product Information
- 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
- Product quantity
- 3,096 bottles
- Reason for recall
- Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bracco Diagnostics Inc
- Address
-
259 Prospect Plains Rd., Building H
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-914-2013
- Event ID
- 66032
- Recall initiation date
- July 19, 2013
- Center classification date
- August 22, 2013
- Code info
- Lot #65846
- More code info
- —