DOBUTamine Injection — Class I drug recall D-1540-2014
Terminated recall by Hospira Inc., reported 2014-08-27, distributed nationwide. Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also g
| Recall number | D-1540-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-01-10 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 123,900 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-2344, 00409-2344-01, 00409-2344-02, 00409-2344-62 |
| Lot numbers | 03/15, 27-352-DK |
Product
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Reason for recall
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
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-1540-2014. 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.