Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

Recall Number: D-1667-2012

Firm: Apotex Corp.

Classification: Class III

Status: Terminated

Report Date: 20120905

Initiation Date: 20110615

Termination Date: 20120918

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.