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

FDA recall notice · announced September 5, 2018 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide USA
Lot/code information: Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Quantity: 8,574 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.