Class III
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- August 8, 2018
- Posted
- September 5, 2018
- Recall Number
- D-1168-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,574 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Distribution
Nationwide USA
Lot / Code Info
Lot# 6K89A, 6K90A, 6K92A, exp 9/18
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