FDA Drug recall D-611-2013
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL…
- FDA Drug
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL… by Hospira, citing lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-611-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-04 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Identifiers
| code_info | Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/1…Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12 |
|---|
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-611-2013%22
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