FDA Drug recall D-0004-2015
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02
- FDA Drug
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02 by Baxter Healthcare, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0004-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Reason
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.
Identifiers
| ndc | 0338-1005-02 |
|---|---|
| ndc | 0338-1005-03 |
| ndc | 0338-1007-02 |
| ndc | 0338-1007-03 |
| ndc | 0338-1009-02 |
| code_info | Lot# P303172; Exp. 12/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.