FDA Drug recall D-686-2013
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, Manufactur…
- FDA Drug
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of 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, Manufactur… by Hospira, citing presence of Particulate Matter: visible particles were identified floating in the primary container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-686-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-02 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Identifiers
| ndc | 0409-1207-13 |
|---|---|
| ndc | 0409-1207-03 |
| code_info | Lot 07-067-DK Exp. 07/13 |
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-686-2013%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.