FDA Recall D-1540-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 550 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Reason for recall
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Recall record
- Recall number
D-1540-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico.
- Recall initiated
- 2014-01-10
- Classified by FDA Center
- 2014-08-18
- FDA published
- 2014-08-27
- Terminated
- 2015-07-14
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- DOBUTAMINE
- Generic name(s)
- DOBUTAMINE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-2344- Route(s)
- INTRAVENOUS