Azelastine Hydrochloride Spray, Metered
FDA Recall NDC 60505-0833
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Azelastine Hydrochloride (NDC 60505-0833). A significant event, classified as Class III, was initiated on Jun 15, 2011 by Apotex Corp.. The reported reason for this action was: "CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Jun 15, 2011
Sep 05, 2012
963,407 bottles
Recall Profile & Regulatory Data
Event ID
62930
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 18, 2012
Product Description
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.
Batch or Lot Expiration Information
Lot# : JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Affected Packages Involved in this Recall
60505-0833-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
