Drug product
Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21
D-0566-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 406 vials
- Official record key
drug-enforcement:D-0566-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: C5804AA
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations