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Life sciences · Safety recall
U.S. Food and Drug Administration · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Safety recall.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
FDA enforcement report D-0012-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: BioSpectra, Inc.. Initiated as: Voluntary: Firm initiated. Product: Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25 Reason for recall: Failed stability specifications Distribution: CA