Bracco Recalls E-Z-CAT Dry Barium Sulfate Due to Viscosity Failures
Bracco Diagnostic Inc. is recalling E-Z-CAT Dry Barium Sulfate for Suspension because the product failed stability specifications for viscosity.
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 indicates the product is unlikely to cause adverse health consequences. The issue is a stability specification failure (viscosity) with no reported injuries or illnesses.
Plain-English summary
Bracco Diagnostic Inc. is recalling E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, NDC 32909-727-01. The recall involves 1,008 boxes distributed nationwide. The affected lots are 00513716 and 00514712, with an expiration date of 03/2016.
The recall was initiated due to out-of-specification results for viscosity, which failed to meet stability specifications. The product is manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM Inc., located in Lake Success, NY.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
- Manufacturer
- Bracco Diagnostic Inc
- Hazard
- Affected units
- 1,008
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 (3)
- Lot #: 00513716
- 00514712
- Exp 03/2016
Distribution
Distributed nationwide across the United States.
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