DOPamine Hydrochloride and 5% Dextrose INJ — Class II drug recall D-0004-2015
Terminated recall by Baxter Healthcare Corp., reported 2014-10-08, distributed nationwide. Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufactur
| Recall number | D-0004-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-09-29 |
| Classified | 2014-10-02 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2016-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 11,808 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-1005, 00338-1005-02, 00338-1005-03, 00338-1007, 00338-1007-02, 00338-1007-03, 00338-1009, 00338-1009-02 |
| Lot numbers | 12/14, P303172 |
Product
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Reason for recall
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
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-0004-2015. 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.