FDA Drug recall D-184-2013
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 6…
- FDA Drug
- Class II
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class II recall of HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 6… by Hospira, citing lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-184-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-22 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Reason
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Identifiers
| ndc | 0409-1555-64 |
|---|---|
| ndc | 0409-1555-54 |
| code_info | Lot # 10-199-JT Exp. 10/13 |
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-184-2013%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.