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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
Related recalls
Same manufacturer · Bracco Diagnostics Inc
See all →- ModerateBracco Recalls E-Z-Paste Barium Sulfate Due to Preservative Failure
FDA (Drugs) · 2018-04-04
- LowBracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure
FDA (Drugs) · 2013-08-28
- ModerateBracco Recalls Gastrografin Due to Potential Foreign Particles
FDA (Drugs) · 2013-08-21
- ModerateBracco Recalls CardioGen-82 Generators Due to Strontium-82 Levels Exceeding Limits
FDA (Drugs) · 2012-10-03
- LowBracco Recalls Multihance Injection Vials Due to Potential Underfill
FDA (Drugs) · 2012-09-05
Same hazard · stability failure
See all →- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
Similar recalls
- LowBracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure
FDA (Drugs) · 2013-08-28
- LowBracco Recalls E-Z-CAT Dry Barium Sulfate Due to Viscosity Failures
FDA (Drugs) · 2015-07-01
- ModerateBracco Recalls E-Z-HD Barium Sulfate Due to Low Potency
FDA (Drugs) · 2014-08-20
- ModerateClobazam Oral Suspension Recalled for Failed Stability Specifications
FDA (Drugs) · 2022-01-26
- LowBracco Recalls E-Z-GAS Antacid Due to Subpotent Drug Levels
FDA (Drugs) · 2014-10-15
- ModeratePharmedium Recalls Rocuronium Bromide Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19