Bracco Recalls Choletec Kits Due to Particulate Matter
Bracco Diagnostic Inc is recalling Choletec kits because they may contain particulate matter, including potential charcoal particulates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Bracco Diagnostic Inc is recalling Choletec (Mebrofenin) kits, which are used for the preparation of Technetium Tc 99m Mebrofenin for intravenous diagnostic use. The recall is being conducted because the product may contain particulate matter, with a specific potential for charcoal particulates.
The affected product is Choletec, NDC 0270-0083-20, manufactured for Bracco Diagnostics Inc. by Hollister-Stier Laboratories LLC. The recall covers 196,280 vials distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall notice.
Healthcare providers and patients should stop using the affected lots and contact Bracco Diagnostic Inc or their supplier for further instructions. The FDA has classified this recall as Class III, indicating that while the product may not comply with FDA regulations, it is unlikely to cause adverse health consequences.
The recalled product
- Product
- CHOLETEC (MEBROFENIN)
- Brand
- CHOLETEC
- Manufacturer
- Bracco Diagnostic Inc
- Hazard
- Affected units
- 196,280
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 (10)
- Lot #s: C0672
- Exp 09/30/2012
- C0689
- Exp 10/31/2012
- C0723
- Exp 12/31/2012
- C0799
- Exp 02/28/2013
- C0852
- Exp 05/31/2013.
Distribution
Distributed nationwide across the United States.
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