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.
Reason for recall: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Recall initiated: 20110615
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated