Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Summary
The FDA issued a Class II for Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic by BioSpectra, Inc.. Reason: Failed stability specifications.
Details
Source
Drug Recall
External ID
D-0012-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Lot/Code Info: Lot#: TRIS -E04-0226-0016; Exp 2/29/28
Quantity Affected: 200 kg
Reason for Recall
Failed stability specifications
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Bangor, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioSpectra, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioSpectra, Inc. have FDA actions?
This is the only FDA action we have on record for BioSpectra, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0012-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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