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

Class II FDA enforcement event 72198. Recall start date: 14 Sep 2015. Status in the FDA record: Terminated. Termination date: 27 Jun 2017.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Valeant Pharmaceuticals North America LLC started this device recall on 14 Sep 2015. The firm address in the FDA record is in Bridgewater, NJ. FDA put the recall in Class II. FDA event 72198 has 1 product record. The first FDA enforcement report date is 16 Dec 2015. The record gives the status Terminated, with the termination date 27 Jun 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 72198: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0371-2016	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	61 units	Class II	Terminated	16 Dec 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Valeant Pharmaceuticals North America LLC
Initiated	Product (first record)	Type	Class	Records
30 Jan 2019	Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottle	Drug	Class III	5
24 Aug 2018	Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant	Drug	Class II	3
10 Jul 2018	Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating	Drug	Class III	1
28 Jun 2017	Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA M	Drug	Class III	1
20 Mar 2017	CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America	Drug	Class III	2
10 Jun 2016	SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceut	Drug	Class III	1
23 May 2016	Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valea	Drug	Class III	1
4 Sep 2015	Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 921	Drug	Class II	1
18 Apr 2015	Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Can	Drug	Class III	2
17 Apr 2015	Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA	Drug	Class II	1

Valeant Pharmaceuticals North America LLC: all 14 events

Official channels

FDA enforcement report Z-0371-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72198. https://recallregister.com/fda/ii/72198/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
What quantity of product is in FDA event 72198?: The FDA record gives this quantity: 61 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.