Bracco Recalls E-Z-HD Barium Sulfate Due to Low Potency
Bracco Diagnostic Inc is recalling E-Z-HD (barium sulfate) bottles because routine stability testing revealed low pH and assay results.
What this means for you
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a subpotent drug (low potency) rather than a toxic contaminant or structural defect, fitting the Moderate severity criteria for minor labeling or quality errors without reported harm.
Plain-English summary
Bracco Diagnostic Inc is recalling 216,792 bottles of E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle. The product is a prescription-only radiographic contrast agent manufactured by E-Z-EM Canada Inc. The recall covers specific lots with expiration dates of 05/15 and 06/15.
The recall was initiated because routine stability testing after 36 months resulted in low out-of-specification values for both pH and assay. This indicates the product may be subpotent, meaning it may not contain the intended amount of active ingredient or may not perform as expected.
The affected product was distributed nationwide and in Puerto Rico. Patients and healthcare providers should stop using the recalled lots and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.
The recalled product
- Product
- E-Z-HD (BARIUM SULFATE)
- Brand
- E-Z-HD
- Manufacturer
- Bracco Diagnostic Inc
- Affected units
- 216,792
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 (16)
- Lot #'s: 64205
- 64206
- 64200
- 64201
- 64202
- 64203
- 64204
- 64207
- 64264
- Exp 05/15
- 64265
- 64267
- 64268
- 64270
- 64271
- Exp 06/15
Distribution
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