0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Reported: October 3, 2012 Initiated: September 21, 2012 #D-1689-2012
Product Description
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Reason for Recall
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 897,496 containers
- Distribution
- Nationwide and Puerto Rico
- Location
- Round Lake, IL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Recalled by Baxter Healthcare Corp.. Units affected: 897,496 containers.
Why was this product recalled? ▼
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2012. Severity: Moderate. Recall number: D-1689-2012.
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