Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic
FDA device recall Z-0371-2016 · posted 2015-12-04 · Terminated
Recall details
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Reason for recall
- SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 61 units
- Distribution
- AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
- Date initiated
- 2015-09-14
- Date posted
- 2015-12-04
- Date terminated
- 2017-06-27
- Location
- Bridgewater, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE (K870051) | Viratek, Inc. | 1987-10-06 |
| (SPAG) MODEL SPAG-2 6000 SERIES (K871427) | Viratek, Inc. | 1987-10-06 |