Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Azelastine HCl Nasal Solution Recalled for Failure to Meet Stability Standards

Agency Publication Date: February 13, 2018

Summary

Sun Pharmaceutical is voluntarily recalling 17,554 bottles of Azelastine HCl Nasal Solution (Nasal Spray) 0.1%. This prescription medication, used for allergy symptoms, was found to have inconsistent droplet sizes during long-term stability testing, which means the spray may not deliver the medication as intended over time. The affected products were distributed nationwide in 30 mL bottles and include those with expiration dates in November and December 2018.

Risk

The failure to meet droplet size requirements during stability testing could result in inconsistent dosing or reduced effectiveness of the medication during use.

What You Should Do

Locate your Azelastine HCl Nasal Solution (Nasal Spray) 0.1% 30 mL bottle and check the National Drug Code (NDC) 47335-779-91 and identifying codes on the label.
Check for lot codes JKR7706A with an expiration date of December 2018 or JKR7705A with an expiration date of November 2018.
Contact your healthcare provider or pharmacist for guidance if you are using this medication from an affected lot.
Return any unused product from the affected lots to your pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. for further instructions.
If you have questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (30 mL Bottle)

Model:

NDC 47335-779-91

Recall #: D-0417-2018

Lot Numbers:

JKR7706A (Exp December 2018)

JKR7705A (Exp November 2018)

Date Ranges: November 2018 - December 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79145

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Manufactured In: United States, India

Units Affected: 17554 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your Azelastine HCl Nasal Solution (Nasal Spray) 0.1% 30 mL bottle and check the National Drug Code (NDC) 47335-779-91 and identifying codes on the label.

Check for lot codes JKR7706A with an expiration date of December 2018 or JKR7705A with an expiration date of November 2018.

Contact your healthcare provider or pharmacist for guidance if you are using this medication from an affected lot.

Return any unused product from the affected lots to your pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. for further instructions.

If you have questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.