D-0993-2019 Class II Terminated
FDA drug recall D-0993-2019 was initiated by Akorn, Inc. on February 22, 2019 and is designated Class II. 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. The recall status is terminated (terminated August 9, 2022). Affected quantity: 51,456 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- February 22, 2019
- Termination Date
- August 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,456 bottles
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.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot 7B71A, Exp 01/2020