FDA Drug recall D-502-2013
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-…
- FDA Drug
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-… by Hospira, citing lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-502-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Reason
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Identifiers
| ndc | 0409-2347-31 |
|---|---|
| ndc | 0409-2347-32 |
| ndc | 0409-2346-31 |
| ndc | 0409-2346-32 |
| ndc | 0409-3724-11 |
| ndc | 0409-3724-32 |
| ndc | 0409-0025-01 |
| ndc | 0409-0025-10 |
| ndc | 0409-0151-01 |
| ndc | 0409-0151-10 |
| ndc | 0409-1100-01 |
| ndc | 0409-1100-10 |
| code_info | Lot 11-309-KL |
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-502-2013%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.