Recalls / Class II
Class IID-023-2014
Product
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Intravenous
- NDCs
- 0409-1134, 0409-1135
- Affected lot / code info
- Lot #17368EV Exp 08/13
Why it was recalled
Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 29,700 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-16
- FDA classified
- 2013-12-02
- Posted by FDA
- 2013-12-11
- Terminated
- 2014-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-023-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.