Reported Sep 5, 2018 · Terminated
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
Azelastine HCl Ophthalmic Solution 0.05%6 mL in 10 mL HDPE bottle1 bottle per boxRx only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
- Lot codes and dates
Lot# 6K89A6K90A6K92Aexp 9/18
- Amount recalled
- 8,574 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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