Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Recalled by Valeant Pharmaceuticals North America LLC Due to SPAG-2 6000 Lot J3522070 was released to commerce...

Date: September 14, 2015
Company: Valeant Pharmaceuticals North America LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Valeant Pharmaceuticals North America LLC directly.

Affected Products

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

Quantity: 61 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 13 states: AL, AZ, CA, CO, IL, MO, NY, NC, OH, PA, SC, TX, UT

Affected (13 states)Not affected

About Valeant Pharmaceuticals North America LLC

Valeant Pharmaceuticals North America LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report