Recalls / Class III
Class IIID-0417-2018
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
- Brand name
- Azelastine Hydrochloride
- Generic name
- Azelastine Hydrochloride
- Active ingredient
- Azelastine Hydrochloride
- Route
- Nasal
- NDC
- 47335-779
- FDA application
- ANDA090423
- Affected lot / code info
- JKR7706A December 2018 JKR7705A November 2018
Why it was recalled
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
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 17554 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-02-05
- FDA classified
- 2018-02-13
- Posted by FDA
- 2018-02-21
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0417-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.