D-0417-2018 Class III Terminated
FDA drug recall D-0417-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Feb 5, 2018 and is designated Class III. 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… The recall status is terminated (terminated Mar 11, 2019). Affected quantity: 17554 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Feb 5, 2018
- Termination Date
- Mar 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17554 bottles
Product Description
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
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
Distribution Pattern
Nationwide
Code Information
JKR7706A December 2018 JKR7705A November 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0417-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026