0 — Class I drug recall D-481-2015
Terminated recall by Baxter Healthcare Corp, reported 2015-04-15, distributed nationwide. Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, ident
| Recall number | D-481-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2015-04-08 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 542,080 containers |
| Reason classes | specification failure |
| NDC | 00338-0553, 00338-0553-11, 00338-0553-18 |
| Lot numbers | 05/15, P317842, P317891 |
Product
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
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-481-2015. 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.