STERILE WATER

Generic: WATER

Fresenius Kabi USAManufacturer

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute

WATERActive Substance

1984-01-16Original Approval

STERILE WATER is FDA application ANDA088400, sponsored by FRESENIUS KABI USA. 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 II2023-02-23

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,

CGMP Deviations: Potential product carryover.

Class II2025-08-26

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Class II2025-12-22

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6

Presence of particulate matter: plastic particles from the bottle rim were observed floating into th

Class II2022-04-13

Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06

cGMP deviations: Temperature abuse

Class II2023-01-12

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vi

CGMP Deviations: potential for trace amounts of product carryover.

Class II2021-05-03

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed b

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Class II2026-04-02

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is remov

STERILE WATER

Recalls

Top Reported Reactions