SODIUM BICARBONATE

Generic: SODIUM BICARBONATE

Glenmark Pharmaceuticals Inc.Manufacturer
INTRAVENOUSRoute
SODIUM BICARBONATEActive Substance
2025-06-26Original Approval

SODIUM BICARBONATE is FDA application ANDA219701, sponsored by ADAPTIS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-03-07
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou

Lack of Assurance of Sterility

Class I2023-10-18
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca

Presence of Particulate Matter: Silicone

Class I2023-12-21
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only

Presence of Particulate Matter; identified as glass

Class I2022-10-04
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,

Defective Container: Complaints received of vial breakage and glass flying when pressurized while pr

Class II2025-08-04
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 6004

Lack of Assurance of Sterility.

Class I2022-11-28
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,

Defective Container: Complaints received of vial breakage and glass flying when pressurized while pr

Class II2025-07-30
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impuri

Top Reported Reactions

1
NAUSEA
21,679 reports
2
DIARRHOEA
21,638 reports
3
FATIGUE
21,466 reports
4
DYSPNOEA
17,858 reports
5
DRUG INEFFECTIVE
17,758 reports
6
HEADACHE
16,041 reports
7
PAIN
15,141 reports
8
OFF LABEL USE
14,816 reports
9
VOMITING
14,617 reports
10
CHRONIC KIDNEY DISEASE
14,312 reports