Valeant Pharmacueticals International recalls Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A n…

Recall date

September 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0674-2016

FDA classification

Class II

Brand / firm

Valeant Pharmacueticals International

Sold / distributed

USA (nationwide) Distribution and Internationally to Canada and France.

Why it was recalled

The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.