D-0425-2015 Class II Terminated
FDA drug recall D-0425-2015 was initiated by Baxter Healthcare Corp. on Mar 18, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. The recall status is terminated (terminated Feb 24, 2016). Affected quantity: 597,498 units total.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 1, 2015
- Initiation Date
- Mar 18, 2015
- Termination Date
- Feb 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 597,498 units total
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.
Distribution Pattern
Nationwide
Code Information
Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0425-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026