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

FDA recall notice · announced September 5, 2012 · Bracco Diagnostics

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Notes

Distribution: Nationwide
Lot/code information: Lot S1P272A Expiry Date: December 2014
Quantity: 47,750 vials
Status: Terminated
Products in this recall event:
- 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 (D-1663-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.