November 12, 2003
Akorn Has Recalled Indigo Carmine Injection
The FDA has released the following information.
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.
Lot number 61013, Expiration date 06/05.
Akorn, Inc., Buffalo Grove, IL, by letter on September 29, 2003. Firm
initiated recall is ongoing.
The lot was manufactured from active (drug) pharmaceutical ingredient which
failed to meet assay specifications.
VOLUME OF PRODUCT IN COMMERCE