Glycophos Injection
Generic name:sodium glycolate
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.
On This Page
IMPORTANT PRESCRIBING INFORMATION
October 30, 2017
Subject: Temporary importation of Glycophos to address drug shortage issues
Dear Healthcare Professional,
Due to the critical shortage of phosphate injection in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to provide an alternative treatment option during this critical shortage period. Fresenius Kabi USA has initiated temporary importation of a GlycophosTM 20 mL Injection Single Dose Plastic Vial into the U.S. market. This product is marketed in Europe, and is manufactured in the Fresenius Kabi Norway plant.
At this time, no other entity except Fresenius Kabi USA is authorized by the FDA to import or distribute GlycophosTM 20 mL Injection Single Dose Plastic Vial in the U.S. FDA has not approved Fresenius Kabi's GlycophosTM in the United States.
Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentation of phosphate injection:
Glycophos 20 mL Sterile Concentrate Single Dose Plastic Vial | |
| Chemical Name | Sodium Glycerophosphate |
| Phosphate Concentration | 1 mMol per mL. |
| Type of Phosphate | Organic |
| Sodium | 2 mEq per mL. |
| Fill Volume | 20 mL. |
| Description | Single Dose Plastic Vial |
| Manufacturer | Fresenius Kabi Norge A/S |
The vial and carton labels will display the text used when marketing the product in English speaking countries.
It is important to note that there are some key differences in the formulation and labeling
between the current U.S. marketed phosphate injection products and Glycophos that you need to be aware of:
