Drug 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
D-1168-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 80767
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,574 bottles
- Official record key
drug-enforcement:D-1168-2018
Official wording
Reason: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Code information: Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
out-of-specification