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 age1 to 10 years of age
How to check it without Arxo's tools
- 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). - 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
| Date | Institution | Channel | Reference |
|---|---|---|---|
| 2026-10-31 | Baxter Healthcare Corporation | ||
| 2026-10-31 | U.S. Food and Drug Administration, Center for Drug Evaluation and Research |
Responses
No response recorded.
History
- 2026-10-31Confirmed by Arxo
- 2026-10-31Reported to Baxter Healthcare Corporation (e-mail)
- 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.