FDA Drug recall D-1583-2014
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
- FDA Drug
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03 by Baxter Healthcare, citing lack of Assurance of Sterility; complaints of mold in the overpouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1583-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-30 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Reason
Lack of Assurance of Sterility; complaints of mold in the overpouch
Identifiers
| ndc | 0338-0049-01 |
|---|---|
| ndc | 0338-0049-02 |
| ndc | 0338-0049-03 |
| ndc | 0338-0049-04 |
| ndc | 0338-0049-10 |
| ndc | 0338-0049-41 |
| ndc | 0338-0049-11 |
| ndc | 0338-0049-31 |
| ndc | 0338-0049-48 |
| ndc | 0338-0049-18 |
| ndc | 0338-0049-38 |
| ndc | 0338-0043-03 |
| ndc | 0338-0043-04 |
| code_info | Lot #C926642, Product Code: 2B1323N |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1583-2014%22
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