Valeant Pharmaceuticals North America LLC recalls Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic…

Recall date

September 14, 2015

Source

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

Recall number

Z-0371-2016

FDA classification

Class II

Brand / firm

Valeant Pharmaceuticals North America LLC

Sold / distributed

AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX

Why it was recalled

SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

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 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