Biospectra, Inc.: Biospectra Tris/tromethamine, Usp, Gmp, Api Grade, Manufactured At
Recall Summary BioSpectra, Inc. is recalling Biospectra Tris/Tromethamine, USP, GMP, API Grade (a pharmaceutical ingredient), distributed in California, because it failed stability testing requirements. This is a Class II recall, meaning the product could cause adverse health effects. The affected product was manufactured at the company's facility in Bangor, Pennsylvania.
- Recalling firm
- BioSpectra, Inc.
- Product
- Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
- Reason
- Failed stability specifications
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-29
- Status
- Ongoing
- Areas affected
- CA
- Distribution
- CA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c626ba00-1f06-4063-8439-e96e9a2090cc