Valeant SPAG-2 6000 Aerosol Generator Recalled for Missing Particle Size Testing
Valeant Pharmaceuticals is recalling 61 units of the SPAG-2 6000 aerosol generator because they were released without required particle size testing.
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. The hazard involves a quality control deviation (missing testing) without reported illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 61 units of the SPAG-2 6000 Small Particle Size Aerosol Generator, Lot #J3522070. The device is a pneumatic flow system indicated for the administration of Viazole, using a nebulizer to generate a fine aerosol of hydrated Virazole.
The recall was initiated because the affected units were released to commerce without being tested for particle size, as required by quality control procedure SPAG-2515. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The affected units were distributed in Alabama, Arizona, California, Colorado, Illinois, Ohio, Missouri, North Carolina, New York, Pennsylvania, South Carolina, Utah, and Texas. Consumers and healthcare providers should stop using the affected units and contact Valeant Pharmaceuticals for further instructions.
The recalled product
- Product
- Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Affected units
- 61
Distribution
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