lipid injectable emulsion (soybean and olive oils): 2.4, Table 1 and 2.4, Table 1 give different instructions for one patient

2.4, Table 1 reads “Birth to 2 years of age”. 2.4, Table 1 reads “2 to less than 12 years of age”. Example: A child aged exactly 2 years matches both rows, with different initial doses. The text is in this label.

Consequence

Potential effect on a prescribing decision: low; careful reading of the whole label usually resolves it. Arxo does not say which instruction is correct and gives no dose.

Jurisdiction

United States — federal

Act

lipid injectable emulsion (soybean and olive oils) prescribing information (SPL set ID ae98eb03-c0e7-49d1-b024-77968e3d9d6e)

Place

2.4, Table 1 and 2.4, Table 1

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

Reproduced by execution. Quotations are verbatim from the official material; translations are ours and marked.

Birth to 2 years of age

2 to less than 12 years of age

How to check it without Arxo's tools

1. Open Prescribing information, Baxter Healthcare Corporation, SPL set ID ae98eb03-c0e7-49d1-b024-77968e3d9d6e, version 24 (DailyMed) and find 2.4, Table 1. Compare the text with the quotation above. A copy is kept in this register: baeaa6b77aeadee0-ae98eb03-c0e7-49d1-b024-77968e3d9d6e-v24.xml (SHA-256 baeaa6b77aeadee00d8185e14152e45146911fc9d6eae2a81940313efdb85bda, 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

• Baxter Healthcare Corporation — 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 Baxter Healthcare Corporation (e-mail)
3. 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-2026-0317, https://arxo.io/findings/ARXO-2026-0317/ (status as of 2026-10-31). Data: ARXO-2026-0317.json.