Drug 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
D-0417-2018
Product summary
- Event
- Event 79145
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17554 bottles
- Official record key
drug-enforcement:D-0417-2018
Official wording
Reason: 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
Code information: JKR7706A December 2018 JKR7705A November 2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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