Recalls / Class II
Class IID-0414-2019
Product
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
- Affected lot / code info
- Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
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
- 149,159 5mL bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-08
- FDA classified
- 2019-01-28
- Posted by FDA
- 2019-02-06
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0414-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.