Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,
Recalled September 5, 2018 · FDA recall D-1168-2018 · Akorn
Hazard
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide · FDA Class III
Units
8,574 bottles
Sold at
Nationwide USA
Description
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Product
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →