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

Recall Insight

This FDA Drug action (record #D-1663-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on April 16, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Bracco Diagnostics Inc is listed as the recalling firm, operating out of Monroe Township, NJ. Federal records indicate 47,750 vials units are affected.

The documented reason for this recall is: Short Fill: The product is being recalled due to a potential underfill of the affected vials. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.