Sun Pharmaceutical Industries, Inc. recalls Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical
Recalled February 21, 2018 · FDA recall D-0417-2018 · Sun Pharmaceutical Industries
Hazard
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 · FDA Class III
Units
17554 bottles
Sold at
Nationwide
Description
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
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
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →