Bracco Recalls VoLumen Barium Sulfate Suspension Due to Stability Failure
Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension because the product failed stability testing for preservative content.
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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottles, NDC 32909-945-03. The recall involves 54,648 bottles distributed nationwide, including Puerto Rico. The specific lot number is 67603, with an expiration date of 2/2014.
The recall was initiated because the product failed stability testing and is below specification for preservative content. This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Healthcare providers and patients should discontinue use of the affected product and contact Bracco Diagnostics Inc for further instructions or a replacement.
The recalled product
- Product
- VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
- Manufacturer
- Bracco Diagnostics Inc
- Category
- Drug — Radiographic Contrast
- Hazard
- Affected units
- 54,648
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 (2)
- Lot #: 67603
- Expiry: 2/2014
Distribution
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