potassium phosphates injection: 2.2 has no instruction for a patient the label covers

2.2 reads “4 mEq/dL”. Example: Serum potassium is reported in mEq/L. Read as printed, a threshold of 4 mEq/dL is 40 mEq/L, so a patient with potassium 5.5 mEq/L is below it. The same text is in 13 labels from 10 labelers in the DailyMed release of 29 October 2026.

Consequence

Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction

United States — federal

Act

potassium phosphates injection prescribing information (SPL set ID 475f5cd7-45bd-412a-b419-9962585d6cda)

Place

2.2

Record

Discrepancy

Class

Text of the act

Where it arose

The text of the act

Arxo's conclusion

Confirmed

Official text

Unchanged at last check

Last checked

2026-10-31

Evidence

Contradiction within the text. Quotations are verbatim from the official material; translations are ours and marked.

4 mEq/dL

How to check it without Arxo's tools

1. Open Prescribing information, Fresenius Kabi USA, LLC, SPL set ID 475f5cd7-45bd-412a-b419-9962585d6cda, version 4 (DailyMed) and find 2.2. Compare the text with the quotation above. A copy is kept in this register: 15c7166871663694-475f5cd7-45bd-412a-b419-9962585d6cda-v4.xml (SHA-256 15c7166871663694f9fc349503342f40a2409094396a3824cd8ac5faaefbf2ac, copy of the official file).
2. The finding holds if the quoted passages read as shown and the comparison gives the result stated at the top of this page. If it does not, write to us with the record ID.

How this finding was made

AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31).

Responsible institutions

• Fresenius Kabi USA, LLC — holder of the labeling
• Amneal Pharmaceuticals LLC — holder of the labeling
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to Fresenius Kabi USA, LLC (e-mail)
3. 2026-10-31Reported to Amneal Pharmaceuticals LLC (e-mail)
4. 2026-10-31Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)

Cite this record

Arxo Law, Arxo Findings Register, ARXO-2026-0327, https://arxo.io/findings/ARXO-2026-0327/ (status as of 2026-10-31). Data: ARXO-2026-0327.json.