Recalls / Class II
Class IID-0993-2019
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.
- Affected lot / code info
- Lot 7B71A, Exp 01/2020
Why it was 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.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 51,456 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-02-22
- FDA classified
- 2019-03-11
- Posted by FDA
- 2019-03-20
- Terminated
- 2022-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0993-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.