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Terminated

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

FDA Recall Z-0371-2016 · Posted 2015-12-04

Recalling FirmValeant Pharmaceuticals North America LLC
Recall StatusTerminated
Product CodeCAF
Date Initiated2015-09-14
Date Terminated2017-06-27
Product Quantity61 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K870051SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLEViratek, Inc. · 1987-10-06K871427(SPAG) MODEL SPAG-2 6000 SERIESViratek, Inc. · 1987-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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