Drug 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
D-0414-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 81193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 149,159 5mL bottles
- Official record key
drug-enforcement:D-0414-2019
Official wording
Reason: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Code information: Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter