Drug product
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
D-0993-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 82200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,456 bottles
- Official record key
drug-enforcement:D-0993-2019
Official wording
Reason: 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.
Code information: Lot 7B71A, Exp 01/2020
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-Specification