Drug 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.
D-813-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 268,700 vials
- Official record key
drug-enforcement:D-813-2013
Official wording
Reason: 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.
Code information: Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Distribution pattern: Nationwide and Guam
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter