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.

FDA recall notice · announced July 31, 2013 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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.

Notes

Distribution: Nationwide and Guam
Lot/code information: Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Quantity: 268,700 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.