April 2012 FDA Recall Multihance by Bracco Diagnostics Inc
D-1665-2012 - Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

This Class II 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 lack of assurance of sterility; product recalled due to displacement of the aluminum crimp cap during product usage.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1665-2012

Reason for Recall
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Initiated
04-16-2012
Reported
09-05-2012
Quantity
4,870 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62735
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-13-2013
Product Description About Product Description
Full technical description of the product.
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.

Batch or Lot Expiration Information

Lot# : a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12

Affected Packages Involved in this Recall

0270-5264-16 Multihance
0270-5264-17 Multihance