Recalls / Class II
Class IID-502-2013
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
- Brand name
- Dobutamine In Dextrose
- Generic name
- Dobutamine In Dextrose
- Active ingredient
- Dobutamine Hydrochloride
- Route
- Intravenous
- NDCs
- 0409-0025, 0409-2347, 0409-2346, 0409-3724, 0409-0151, 0409-1100
- FDA application
- NDA020201
- Affected lot / code info
- Lot 11-309-KL
Why it was recalled
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 44,748 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-04-30
- FDA classified
- 2013-06-03
- Posted by FDA
- 2013-06-12
- Terminated
- 2014-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-502-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.