FDA recall D-1663-2012

Bracco Diagnostics Inc · Class III · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-04-16
Report date: 2012-09-05
Termination date: 2013-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1663-2012