0 — Class II drug recall D-0425-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-04-01, distributed nationwide. Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise
| Recall number | D-0425-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-03-18 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 597,498 units |
| Reason classes | sterility, packaging |
| 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 | C926873, C928630, C929844 |
| Expiration dates | 2015-04-30, 2015-05-31 |
Product
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.
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-0425-2015. 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.