Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
SafetyAlerts
November 12,  2003

Akorn Has Recalled Indigo Carmine Injection

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Indigo Carmine Injection, Indigotindisulfonate Sodium Injection USP, 0.8% Solution; 5 mL ampoules, 10 per carton; Rx only, For Intravenous or Intramuscular use. Recall # D-052-4.

CODE
Lot number 61013, Expiration date 06/05.

RECALLING FIRM/MANUFACTURER
Akorn, Inc., Buffalo Grove, IL, by letter on September 29, 2003. Firm initiated recall is ongoing.

REASON
The lot was manufactured from active (drug) pharmaceutical ingredient which failed to meet assay specifications.

VOLUME OF PRODUCT IN COMMERCE
41,420 ampules.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.