0 — Class II drug recall D-1326-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-08-19, distributed in TN, TX. Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer
| Recall number | D-1326-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-07-02 |
| Classified | 2015-08-12 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-05-26 |
| Distributed | TN, TX |
| Quantity | 189,912 containers |
| Reason classes | sterility, specification failure, 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 | C964601 |
| Expiration dates | 2016-04-30 |
Product
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Reason for recall
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
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-1326-2015. 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.