0 — Class II drug recall D-1583-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-09-17, distributed nationwide. Lack of Assurance of Sterility; complaints of mold in the overpouch
| Recall number | D-1583-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-07-30 |
| Classified | 2014-09-05 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2016-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 157,080 containers |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| NDC | 00338-0043, 00338-0043-03, 00338-0043-04, 00338-0049, 00338-0049-01, 00338-0049-02, 00338-0049-03, 00338-0049-04, 00338-0049-10, 00338-0049-11, 00338-0049-18, 00338-0049-31, 00338-0049-38, 00338-0049-41, 00338-0049-48 |
| Lot numbers | C926642 |
Product
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Reason for recall
Lack of Assurance of Sterility; complaints of mold in the overpouch
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1583-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.