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
Reported: September 5, 2018 Initiated: August 8, 2018 #D-1168-2018
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 8,574 bottles
- Distribution
- Nationwide USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product 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. Recalled by Akorn, Inc.. Units affected: 8,574 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2018. Severity: Low. Recall number: D-1168-2018.
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