Recall Z-0371-2016 ยท CAF Nebulizer (Direct Patient Interface)
Valeant Pharmaceuticals North America LLC
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
| Date | Dec 4, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| Reason | SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515. |
| Root cause | Under Investigation by firm |
| Action | Valeant Pharmaceuticals International issued recall letter/return response form dated 9/11/2015 via 2nd day air service Customers were requested to check their inventory for the SPAG-2 device and sgregate it for return shipment. |
| Quantity | 61 units |
| Distribution | AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX |
| FDA record | Open on fda.gov |