Bracco Recalls Multihance Injection Vials Due to Potential Underfill
Bracco Diagnostics is recalling 47,750 vials of Multihance injection due to a potential underfill of the product.
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 by definition is unlikely to cause adverse health consequences. The issue is a potential underfill, which is a packaging or fill-volume defect rather than a contamination or labeling error involving allergens or pathogens.
Plain-English summary
Bracco Diagnostics Inc. is recalling 47,750 vials of Multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml. The affected product is identified by Lot S1P272A with an expiry date of December 2014. The recall was initiated because the product is being recalled due to a potential underfill of the affected vials.
The affected product is a human prescription drug intended for intravenous use. It is manufactured for Bracco Diagnostics Inc. in Princeton, NJ. The distribution pattern for this recall is nationwide.
Consumers and healthcare providers should check their inventory for the specific lot number and expiry date listed above. If the product matches the recalled lot, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- MULTIHANCE (GADOBENATE DIMEGLUMINE)
- Brand
- MULTIHANCE
- Manufacturer
- Bracco Diagnostics Inc
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 47,750
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 S1P272A Expiry Date: December 2014
Distribution
Distributed nationwide across the United States.
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