0 — Class I drug recall D-1208-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-07-15, distributed in PR. Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
| Recall number | D-1208-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-03-24 |
| Classified | 2015-07-06 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2017-02-07 |
| Distributed | PR |
| Countries outside the US | BM |
| Quantity | 202,824 bags |
| Reason classes | specification failure |
| 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 | C963660, C963785, C963884, C964320, C964486, C964890, C965038, C965293 |
| Expiration dates | 2016-07-31 |
Product
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Reason for recall
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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-1208-2015. 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.