DOBUTamine in 5% Dextrose Injection — Class II drug recall D-502-2013
Terminated recall by Hospira Inc., reported 2013-06-12, distributed nationwide. Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
| Recall number | D-502-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-06-03 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 44,748 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-0025, 00409-0025-01, 00409-0025-10, 00409-0151, 00409-0151-01, 00409-0151-10, 00409-1100, 00409-1100-01, 00409-1100-10, 00409-2346, 00409-2346-31, 00409-2346-32, 00409-2347, 00409-2347-31, 00409-2347-32, 00409-3724, 00409-3724-11, 00409-3724-32 |
| Lot numbers | 11-309-KL |
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 for recall
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
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-502-2013. 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.