Heparin Sodium and 0 — Class II drug recall D-1131-2015
Terminated recall by Baxter Healthcare Corp, reported 2015-06-17, distributed nationwide. Subpotent Drug; out of specification results for heparin raw material
| Recall number | D-1131-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2015-06-03 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2017-03-14 |
| Distributed | Nationwide (US) |
| Quantity | 145,350 containers |
| Reason classes | potency, specification failure |
| NDC | 00338-0424, 00338-0424-18, 00338-0428, 00338-0428-12, 00338-0431, 00338-0431-03, 00338-0433, 00338-0433-04 |
| Lot numbers | N002998, N003004, N003038 |
| Expiration dates | 2015-12-31, 2016-01-31 |
Product
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
Reason for recall
Subpotent Drug; out of specification results for heparin raw material
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-1131-2015. 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.