US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2021 (5 years ago)

Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What was recalled

Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21

Recalling firm
Cardinal Health Inc.
NDC code
49281-752-21
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0566-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.