Class II · Moderate risk Ongoing
Azelastine HCl Ophthalmic Solution
Reason Lack of Assurance of Sterility
Azelastine HCl Ophthalmic Solution 0.05%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
What was recalled
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
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-718-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1168-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Azelastine recalls
See all
Class II · Moderate risk Ongoing
Azelastine Hydrochloride Nasal Spray
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Dymista
Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk Terminated
Dymista
Reason Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class III · Low risk Terminated
Azelastine HCl Nasal Solution
Reason Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
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