April 2012 FDA Recall Multihance by Bracco Diagnostics Inc
D-1663-2012 - Short Fill
This Class III drug recall was voluntarily initiated by Bracco Diagnostics Inc on April 16, 2012 for the product Multihance. The FDA reported the reason for recall as short fill. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1663-2012
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
04-16-2012
09-05-2012
47,750 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bracco Diagnostics Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-08-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot S1P272A Expiry Date: December 2014
