FDAFDA · Food and drugs·Recall number D-1168-2018
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
Published September 5, 2018 · Recall initiated: August 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide USA
- Lot
- Lot# 6K89A, 6K90A, 6K92A, exp 9/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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