FDA-Drug2026-10-14Class IICHEMICAL
BioSpectra Tris/Tromethamine API recalled for failed stability specifications
What this means
BioSpectra, Inc. is recalling one lot of Tris/Tromethamine, USP, GMP, API Grade manufactured at its Bangor, Pennsylvania facility. The affected lot failed stability testing specifications required for pharmaceutical-grade active ingredients.
- Contact BioSpectra, Inc. if you received lot #TRIS-E04-0226-0016 (expiration 2/29/28)
- Do not use the affected lot in drug manufacturing or compounding
- Quarantine and return the product to BioSpectra for disposition instructions
The agency's original wording
Hazard
Failed stability specifications
Intended for
All ages
Illnesses reported
None reported
Sold states
CA
Affected count
200 kg
Manufactured in
100 Majestic Way, N/A, Bangor, PA, United States
Products
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2027Want us to check the next one for you?
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