FDA Drug recall D-316-2013
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 040…
- FDA Drug
- Class II
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class II recall of Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 040… by Hospira, citing lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-316-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-26 |
| Published | 2013-05-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Identifiers
| ndc | 0409-7299-83 |
|---|---|
| ndc | 0409-7299-73 |
| code_info | Lot 23-320-DK and 23-321-DK Exp. 11/14 |
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-316-2013%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.