Recalls / Class II
Class IID-813-2013
Product
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0409-4888, 0409-1918
- FDA application
- NDA018803
- Affected lot / code info
- Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Why it was recalled
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
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
- 268,700 vials
- Distribution pattern
- Nationwide and Guam
Timeline
- Recall initiated
- 2013-06-27
- FDA classified
- 2013-07-22
- Posted by FDA
- 2013-07-31
- Terminated
- 2015-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-813-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.