Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Reported: March 20, 2019 Initiated: February 22, 2019 #D-0993-2019
Product Description
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 51,456 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.. Recalled by Akorn, Inc.. Units affected: 51,456 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Moderate. Recall number: D-0993-2019.
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