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BioSpectra, Inc.: Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

DrugsSource: FDA (drug) · Date: 2026-10-14

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
BioSpectra, Inc.
Product
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Reason / hazard
Failed stability specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
CA
Recall initiated
2026-07-29
Code info
Lot#: TRIS -E04-0226-0016; Exp 2/29/28
Product quantity
200 kg
Voluntary mandated
Voluntary: Firm initiated
City
Bangor
State
PA
Country
United States
Event id
99564
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