Gentamicin Sulfate Injection USP 80 mg/2 mL — Class II drug recall D-686-2013
Terminated recall by Hospira Inc., reported 2013-07-17, distributed nationwide. Presence of Particulate Matter: visible particles were identified floating in the primary container.
| Recall number | D-686-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-05-02 |
| Classified | 2013-07-08 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 168,300 vals |
| Reason classes | specification failure |
| NDC | 00409-1207, 00409-1207-03, 00409-1207-13 |
| Lot numbers | 07-067-DK, 07/13 |
Product
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Reason for recall
Presence of Particulate Matter: visible particles were identified floating 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-686-2013. 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.