Reported Dec 16, 2015 · Terminated

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

Valeant Pharmaceuticals North America LLC

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 Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867

Is this the product you have?

  • 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
Lot codes and dates
  • Lot #J3522070 Serial numbers

    61 of 61 codes

    • 23461
    • 23463
    • 23466
    • 23467
    • 23468
    • 23469
    • 23472
    • 23475
    • 23477
    • 23479
    • 23480
    • 23481
    • 23482
    • 23484
    • 23485
    • 23486
    • 23487
    • 23488
    • 23489
    • 23490
    • 23491
    • 23492
    • 23493
    • 23495
    • 23503
    • 23504
    • 23505
    • 23506
    • 23507
    • 23508
    • 23509
    • 23510
    • 23512
    • 23513
    • 23514
    • 23515
    • 23517
    • 23520
    • 23521
    • 23524
    • 23529
    • 23530
    • 23531
    • 23532
    • 23535
    • 23536
    • 23540
    • 23547
    • 23558
    • 23560
    • 23568
    • 23569
    • 23570
    • 23571
    • 23572
    • 23579
    • 23587
    • 23589
    • 23590
    • 23592
Amount recalled
61 units

Where it was sold

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.

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 Jun 27, 2017 · Data as of Sep 19, 5:21 PM UTC

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