Recalls / Class II
Class IID-308-2013
Product
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Epidural, Intrathecal, Intravenous
- NDCs
- 0409-3814, 0409-3815
- FDA application
- ANDA073509
- Affected lot / code info
- Lot 15-065-DK, Exp 1SEP2013
Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 26,100 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-08-28
- FDA classified
- 2013-05-01
- Posted by FDA
- 2013-05-08
- Terminated
- 2014-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-308-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.