ARXO-2026-0310 · Reported
imipenem and cilastatin: 2.2, Table 2 and 2.2, Table 2 give different instructions for one patient
2.2, Table 2 reads “4 weeks to 3 months of age”. 2.2, Table 2 reads “1 to 4 weeks of age”. Example: An infant aged exactly 4 weeks matches both rows: every 6 hours and every 8 hours. The same text is in 6 labels from 3 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
- imipenem and cilastatin prescribing information (SPL set ID f41d8abd-7792-4918-1b93-bd83ea01955e)
- Place
- 2.2, Table 2 and 2.2, 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.
4 weeks to 3 months of age1 to 4 weeks of age
How to check it without Arxo's tools
- Open Prescribing information, Merck Sharp & Dohme LLC, SPL set ID f41d8abd-7792-4918-1b93-bd83ea01955e, version 35 (DailyMed) and find 2.2, Table 2. Compare the text with the quotation above. A copy is kept in this register: e6fc7de3962bd7d1-f41d8abd-7792-4918-1b93-bd83ea01955e-v35.xml (SHA-256
e6fc7de3962bd7d1df8fbaec2437ca2eb4def03fcd9612d2dfffd68f1e6b19f1, 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
- Merck Sharp & Dohme LLC — 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 | Merck Sharp & Dohme LLC | ||
| 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 Merck Sharp & Dohme LLC (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-2026-0310, https://arxo.io/findings/ARXO-2026-0310/ (status as of 2026-10-31). Data: ARXO-2026-0310.json.