Reported Jan 27, 2016 · Terminated

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

Valeant Pharmacueticals International

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Valeant Pharmacueticals International · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867

Is this the product you have?

  • 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.
Lot codes and dates
    • SPAG 2 Unit
    • Product Part Number 6002
Amount recalled
1178

Where it was sold

  • Nationwide

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 19, 2017 · Data as of Sep 19, 5:20 PM UTC

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