Valeant Pharmaceuticals North America Model No — Class II medical device recall Z-0371-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2015-12-16, distributed in AL, AZ, CA, CO, IL, MO, NC, NY…. SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control p
| Recall number | Z-0371-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-12-04 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2017-06-27 |
| Distributed | AL, AZ, CA, CO, IL, MO, NC, NY, OH, PA, SC, TX, UT |
| Quantity | 61 units |
| Lot numbers | 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 and 36 more |
| Model numbers | SPAG-2 |
Product
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
Reason for recall
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0371-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.