Drug recall
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic…
FDA recall event 77289 · Class II · Valeant Pharmacueticals International
Key facts
| Event ID | 77289 |
|---|---|
| Recall numbers | Z-0384-2018 |
| Recalling firm | Valeant Pharmacueticals International |
| Product type | Devices |
| Products | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated method, NB-TM-261, In November 2016. The particle size specification set in NB-SPEC-039… |
| Initiation date | Mar 13, 2017 |
| Report date | Jan 24, 2018 |
| Termination date | Jun 18, 2019 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 3009443653 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: