Cardinal Health Recalls Tubersol Tuberculin PPD Due to Temperature Excursions
Cardinal Health is recalling 406 vials of Tubersol Tuberculin PPD due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 406 vials of TUBERSOL (Tuberculin Purified Protein Derivative), a prescription-only intradermal injection used for tuberculosis skin testing. The product is manufactured by Sanofi Pasteur Limited and identified by NDC 49281-752-21.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may affect the stability and efficacy of the biological product.
The affected product was distributed to facilities in Florida, Georgia, and South Carolina. Healthcare providers and patients should discontinue use of the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE)
- Brand
- TUBERSOL
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Biological / Vaccine
- Affected units
- 406
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- C5804AA
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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