BioSpectra, Inc. recall D-0012-2027 · FDA Recalls

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Class IIDrugOngoing

BioSpectra, Inc.

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

Details

Recall number: D-0012-2027
Event ID: 99564
Recall initiated: Jul 29, 2026
Classified: Oct 6, 2026
Reported: Oct 14, 2026
Quantity: 200 kg
Distribution: CA
Initiated by: Voluntary: Firm initiated
Firm notification: Telephone
Firm location: Bangor, PA, United States
Lot / code info: Lot#: TRIS -E04-0226-0016; Exp 2/29/28