FDA Drug recall D-1049-2017
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25…
- FDA Drug
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25… by Hospira A Pfizer, citing lack of Sterility Assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1049-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-15 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira A Pfizer |
| Distribution | PR |
Product
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
Reason
Lack of Sterility Assurance
Identifiers
| code_info | a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383E…a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hospira A Pfizer
- Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I…
FDA Drug · Class II · 2018-03-14 · Hospira A Pfizer - Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx On…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad,…
FDA Drug · Class III · 2017-07-26 · Hospira A Pfizer
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2017%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.