CLASS II Device recall · Reported 16 Dec 2015 · FDA Enforcement Report

Valeant Pharmaceuticals North America Model No. Spag recalled

Valeant Pharmaceuticals North America is recalling Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle, distributed in 13 states. The recall was initiated on 14 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #J3522070 Serial numbers 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 23593

Quantity recalled61 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0371-2016
FDA event ID: 72198
Recalling firm: Valeant Pharmaceuticals North America, Bridgewater, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2015
FDA classified: 4 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Sep 2015	Recall initiated by company
4 Dec 2015	Classified by FDA	+81 days
16 Dec 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arizona California Colorado Illinois Missouri North Carolina New York Ohio Pennsylvania South Carolina Texas Utah

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #J3522070 Serial numbers 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 23593

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Valeant Pharmaceuticals North America

All 25

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Diltiazem HCl CD capsules, 360 mg recalled	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide

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