RecallRadar

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…

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

AgencyFDA Drug
Recall numberD-1073-2019
ClassificationClass I
Statusterminated
Initiated2019-03-15
Published2019-04-10
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionPR

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_infoLots: 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

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.