Class II · Moderate risk
Azelastine HCl Ophthalmic Solution
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
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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
Affected NDC
17478-0718-10
Compare with the code on your package — it is the most precise check available.
Drug: Azelastine Category: Eye Drops & Ophthalmic
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-718-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1168-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Azelastine recalls
See all
Class II · Moderate risk
Azelastine Hydrochloride Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class III · Low risk
Azelastine HCl Nasal Solution
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
Other recalls by Akorn, Inc.
All 2018 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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