Drug recall D-0566-2021

Class II Terminated reported Jun 2, 2021

Product

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

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

C5804AA

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
406 vials
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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