Recalls / Active ingredient / Dextrose Monohydrate

Dextrose Monohydrate

33 FDA drug recalls involving the active ingredient “Dextrose Monohydrate” — 7 Class I.

Date	Class	Product	Firm
2024-06-18	Class II	DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe E	Fresenius Medical Care Holdings, Inc.
2024-06-17	Class II	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administr	Baxter Healthcare Corporation
2023-12-28	Class II	DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fre	Fresenius Medical Care Holdings, Inc.
2023-08-11	Class II	Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull	Baxter Healthcare Corporation
2023-08-11	Class II	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX I	Baxter Healthcare Corporation
2023-05-09	Class II	Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Con	B. Braun Medical Inc
2023-03-15	Class II	Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Am	Baxter Healthcare Corporation
2023-03-15	Class II	Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only,	Baxter Healthcare Corporation
2023-03-01	Class II	Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Cont	B. Braun Medical Inc
2021-11-30	Class II	5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 600	Pfizer Inc.
2021-04-28	Class III	DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Ex	Fresenius Medical Care Holdings, Inc.
2021-04-28	Class III	DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL ba	Fresenius Medical Care Holdings, Inc.
2021-04-28	Class III	DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exc	Fresenius Medical Care Holdings, Inc.
2021-04-28	Class III	DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exc	Fresenius Medical Care Holdings, Inc.
2021-04-28	Class III	DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2	Fresenius Medical Care Holdings, Inc.
2021-04-14	Class II	Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags	Fresenius Medical Care, North America
2019-11-27	Class II	25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 6	Pfizer Inc.
2019-06-13	Class II	Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Conta	B. Braun Medical Inc
2019-01-02	Class II	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container ba	Baxter Healthcare Corporation
2017-12-20	Class II	DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-	Fresenius Medical Care Renal Therapies Group, LLC
2017-07-06	Class II	5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfie	Baxter Healthcare Corporation
2017-04-21	Class I	Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx on	Hospira Inc.
2015-12-15	Class I	Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusi	Baxter Healthcare Corp.
2015-04-28	Class II	KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfit	Fresenius Kabi USA, LLC
2015-03-24	Class I	10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pit	Baxter Healthcare Corp.
2015-03-24	Class I	5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts	Baxter Healthcare Corp.
2015-03-18	Class II	5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Co	Baxter Healthcare Corp.
2015-03-05	Class II	5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged	Hospira Inc.
2014-08-07	Class I	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II containe	Baxter Healthcare Corp.
2014-02-11	Class I	Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter	Baxter Healthcare Corp.
2013-11-21	Class I	5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporat	Baxter Healthcare Corp.
2013-07-24	Class II	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, B	Baxter Healthcare Corp.
2013-05-21	Class II	5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b)	Baxter Healthcare Corp.