heparin sodium injection: Highlights, Contraindications has no instruction for a patient the label covers

Highlights, Contraindications reads “Severe thrombocytopenia”. Example: Highlights lists severe thrombocytopenia as a contraindication; section 4 does not, and section 4 lists HIT or HITT history and hypersensitivity, which Highlights omits. The same text is in 28 labels from 16 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

heparin sodium injection prescribing information (SPL set ID 9207cef5-4cec-41e7-a351-29ba726feb44)

Place

Highlights, Contraindications

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.

Severe thrombocytopenia

How to check it without Arxo's tools

1. Open Prescribing information, Fresenius Kabi USA, LLC, SPL set ID 9207cef5-4cec-41e7-a351-29ba726feb44, version 3 (DailyMed) and find Highlights, Contraindications. Compare the text with the quotation above. A copy is kept in this register: 60b2a91054e02f16-9207cef5-4cec-41e7-a351-29ba726feb44-v3.xml (SHA-256 60b2a91054e02f1627b236796cd1349a91ff1c0633824b1aab39b75bcb695139, 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
• Hikma Pharmaceuticals USA Inc. — 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 Hikma Pharmaceuticals USA Inc. (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-2026-0322, https://arxo.io/findings/ARXO-2026-0322/ (status as of 2026-10-31). Data: ARXO-2026-0322.json.