April 2013 FDA Recall Dobutamine In Dextrose by Hospira Inc.
D-502-2013 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Hospira Inc. on April 30, 2013 for the product Dobutamine In Dextrose. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-502-2013
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
04-30-2013
06-12-2013
44,748 bags
Recall Profile & Regulatory Data
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.
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.
Hospira 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 and Puerto Rico
10-08-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Batch or Lot Expiration Information
Lot# Lot 11-309-KL
