February 2018 FDA Recall Azelastine Hydrochloride by Sun Pharmaceutical Industries, Inc. (D-0417-2018 - Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station)

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on February 5, 2018 for the product Azelastine Hydrochloride. The FDA reported the reason for recall as sun pharmaceutical is recalling azelastine hcl nasal solution, 0.1% (30 ml bottle) following a failure to meet the % rsd requirement in the test for droplet size during the 6 month long term stability test station. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0417-2018

Reason for Recall
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Initiated
02-05-2018
Reported
02-21-2018
Quantity
17554 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79145
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91

Batch or Lot Expiration Information

Lot# JKR7706A December 2018 JKR7705A November 2018

Affected Packages Involved in this Recall

47335-779-91 Azelastine Hydrochloride