FDA Drug recall D-1073-2019
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only…
- FDA Drug
- Class I
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class I recall of 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only… by Pfizer, citing presence of Particulate Matter; glass particulates.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1073-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | PR |
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Reason
Presence of Particulate Matter; glass particulates
Identifiers
| code_info | Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1073-2019%22
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