Recalls / Class III
Class IIID-1663-2012
Product
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
- Brand name
- Multihance
- Generic name
- Gadobenate Dimeglumine
- Active ingredient
- Gadobenate Dimeglumine
- Route
- Intravenous
- NDC
- 0270-5164
- FDA application
- NDA021357
- Affected lot / code info
- Lot S1P272A Expiry Date: December 2014
Why it was recalled
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Manufacturer
- BRACCO DIAGNOSTICS INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd., Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 47,750 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-16
- FDA classified
- 2012-08-27
- Posted by FDA
- 2012-09-05
- Terminated
- 2013-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1663-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.