Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Recall notice
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
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Source Page by GovInfoNow · govinfonow.com/recall/39746-akorn-inc-recalls-azelastine-hcl-ophthalmic-solution-0-05-6 · Recall date August 8, 2018 · FDA enforcement record: FDA #D-1168-2018
Cite this page
“Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,.” GovInfoNow, recall dated August 8, 2018. https://govinfonow.com/recall/39746-akorn-inc-recalls-azelastine-hcl-ophthalmic-solution-0-05-6. Based on FDA recall #D-1168-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1168-2018%22&limit=1).
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We’ve drafted a message you can send Akorn, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1168-2018 — Akorn, Inc. Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle Hello, I own a Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, that is covered by recall D-1168-2018 from Akorn, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1168-2018 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1168-2018 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.