0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

FDA recall notice · announced June 26, 2013 · Hospira

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

The product

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

Reason for recall

Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
Quantity: 676,872 containers
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02 (D-608-2013)

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