FDA recall D-1667-2012

Apotex Corp. · Class III · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2011-06-15
Report date: 2012-09-05
Termination date: 2012-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1667-2012