Bracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure
Bracco Diagnostics Inc is recalling Tagitol V Barium Sulfate Suspension Lot #65846 because samples failed viscosity specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Bracco Diagnostics Inc is recalling 3,096 bottles of Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w), Net Contents: 20 mL, NDC 32909-814-53. The product is manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., and was distributed nationwide.
The recall was initiated because samples of Lot #65846, taken at 10 months, exhibited results above the upper specification for viscosity. This constitutes a failure of stability specifications.
This is an FDA Class III recall, indicating that the violation is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- 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
- Manufacturer
- Bracco Diagnostics Inc
- Hazard
- Affected units
- 3,096
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #65846
Distribution
Distributed nationwide across the United States.
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