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Class II · ModerateActive recall

Biospectra Tris/Tromethamine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: TRIS -E04-[redacted-phone]; Exp 2/29/28
Where it was soldCA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed stability specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forBioSpectra, Inc.
NDC64173-101-25
Show the full FDA record
Full product labelBiospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Recalling firmBioSpectra, Inc.
DistributionCA
Quantity200 kg
Recall initiated2026-07-29
Report date2026-10-14
Recall completed—
Recall numberD-0012-2027
ClassificationClass II
FDA statusOngoing
Origin on fileBangor PA United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.