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Recall Observatory FDA recall evidence

Drug 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

D-1663-2012

April 16, 2012

Class III

Product summary

Firm
Bracco Diagnostics Inc
Event
Event 62636
Status
Terminated
Classification
Class III
Quantity
47,750 vials
Official record key
drug-enforcement:D-1663-2012

Official wording

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

Code information: Lot S1P272A Expiry Date: December 2014

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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