0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Reported: April 1, 2015 Initiated: March 18, 2015 #D-0425-2015
Product Description
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Reason for Recall
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 597,498 units total
- Distribution
- Nationwide
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03. Recalled by Baxter Healthcare Corp.. Units affected: 597,498 units total.
Why was this product recalled? ▼
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2015. Severity: Moderate. Recall number: D-0425-2015.
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