FDA Recall D-1419-2012
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1137 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
Reason for recall
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Recall record
- Recall number
D-1419-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-04-17
- Classified by FDA Center
- 2012-07-15
- FDA published
- 2012-07-25
- Terminated
- 2015-05-29
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL