D-0414-2019 Class II Terminated
FDA drug recall D-0414-2019 was initiated by Akorn, Inc. on Oct 8, 2018 and is designated Class II. Reason for recall: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. The recall status is terminated (terminated Jun 15, 2022). Affected quantity: 149,159 5mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 6, 2019
- Initiation Date
- Oct 8, 2018
- Termination Date
- Jun 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149,159 5mL bottles
Product Description
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
Reason for Recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0414-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026