Bracco Recalls Gastrografin Due to Potential Foreign Particles
Bracco Diagnostics is recalling one lot of Gastrografin because it may contain black foreign particles.
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 recall is classified as FDA Class II, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The presence of foreign particles is a quality defect that warrants a moderate severity rating.
Plain-English summary
Bracco Diagnostics Inc. is recalling one lot of Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottles. The recall is due to the potential presence of black foreign particles in the product.
The affected product is identified by Lot # 00500512 with an expiration date of 11/15. The NDC for the recalled product is 0270-0445-40. A total of 29,436 bottles were distributed nationwide.
Healthcare providers and patients should stop using the affected lot and contact Bracco Diagnostics for further instructions or a replacement.
The recalled product
- Product
- GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
- Brand
- GASTROGRAFIN
- Manufacturer
- Bracco Diagnostics Inc
- Hazard
- Affected units
- 29,436
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 # 00500512
- Exp. 11/15
UPCs (1)
- 0302700445403
Distribution
Distributed nationwide across the United States.
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