Recalls / Class II
Class IID-0566-2021
Product
Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21
- Brand name
- Tubersol
- Generic name
- Tuberculin Purified Protein Derivative
- Active ingredient
- Tuberculin Purified Protein Derivative
- Route
- Intradermal
- NDC
- 49281-752
- FDA application
- BLA103941
- Affected lot / code info
- C5804AA
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Sanofi Pasteur Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 406 vials
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0566-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.