Arxo Findings Register · Arxo Law

ARXO-2026-0326 · Reported

amino acids injection (PROSOL): Table 2 and Table 2 give different instructions for one patient

Table 2 reads “1 month to 1 year of age”. Table 2 reads “1 to 10 years of age”. Example: A child aged exactly 1 year matches both rows. A child aged exactly 1 month, and a child aged 10 to 11 years, match no row. 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
amino acids injection (PROSOL) prescribing information (SPL set ID cc2ace81-5881-43f1-ba94-41b674adc2fc)
Place
Table 2 and Table 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

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

1 month to 1 year of age
Official publication · Prescribing information, Baxter Healthcare Corporation, SPL set ID cc2ace81-5881-43f1-ba94-41b674adc2fc, version 16 (DailyMed) · Table 2 · version 16 · retrieved 2026-10-29 · SHA-256 06b215dafc8d276126273646c09b513f3cdeca3d99fccb8b932d68fc2fa5e8fa · copy
1 to 10 years of age
Official publication · Prescribing information, Baxter Healthcare Corporation, SPL set ID cc2ace81-5881-43f1-ba94-41b674adc2fc, version 16 (DailyMed) · Table 2 · version 16 · retrieved 2026-10-29 · SHA-256 06b215dafc8d276126273646c09b513f3cdeca3d99fccb8b932d68fc2fa5e8fa · copy

How to check it without Arxo's tools

  1. Open Prescribing information, Baxter Healthcare Corporation, SPL set ID cc2ace81-5881-43f1-ba94-41b674adc2fc, version 16 (DailyMed) and find Table 2. Compare the text with the quotation above. A copy is kept in this register: 06b215dafc8d2761-cc2ace81-5881-43f1-ba94-41b674adc2fc-v16.xml (SHA-256 06b215dafc8d276126273646c09b513f3cdeca3d99fccb8b932d68fc2fa5e8fa, 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

Reported to

DateInstitutionChannelReference
2026-10-31Baxter Healthcare Corporatione-mail
2026-10-31U.S. Food and Drug Administration, Center for Drug Evaluation and Researche-mail

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-2026-0326, https://arxo.io/findings/ARXO-2026-0326/ (status as of 2026-10-31). Data: ARXO-2026-0326.json.