Sun Pharmaceutical Industries, Inc. recalls Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutica…

Recall date

February 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0417-2018

FDA classification

Class III

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Nationwide

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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