FDA recall D-1168-2018

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

Reason for recall

Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2018-08-08

Report date

2018-09-05

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1168-2018