D-0146-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2023
- Initiation Date
- October 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65,006 bottles
Product Description
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;