Recall: D-1667-2012

Class III - Minor Violations

Class IIIClassification

2011-06-15Initiated

TerminatedStatus

Apotex Corp.Firm

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

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.