Bracco Recalls E-Z-Paste Barium Sulfate Due to Preservative Failure
Bracco Diagnostics is recalling E-Z-Paste Barium Sulfate Esophageal Cream because one lot failed stability testing for the preservative methylparaben.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a failed stability specification for a preservative without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bracco Diagnostics Inc. is recalling 2,136 tubes of E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, NDC 32909-770-01. The affected product is identified by Lot # 00538529. This prescription-only radiographic contrast agent was manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc., a subsidiary of Bracco Diagnostics Inc.
The recall was initiated because the product failed stability specifications. Specifically, an out-of-specification (OOS) result was obtained for the preservative assay for methylparaben during stability testing of the single affected lot.
The product was distributed throughout the United States, Hong Kong, and New Zealand. Healthcare providers and patients should stop using the affected lot and contact Bracco Diagnostics for further instructions.
The recalled product
- Product
- E-Z-PASTE (BARIUM SULFATE)
- Brand
- E-Z-PASTE
- Manufacturer
- Bracco Diagnostics Inc.
- Affected units
- 2,136
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 # 00538529
Distribution
Distribution scope not specified by the agency.
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