Recalls / Class II
Class IID-0146-2023
Product
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
- Affected lot / code info
- Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
Why it was recalled
CGMP Deviations:
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 65,006 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-13
- FDA classified
- 2023-01-13
- Posted by FDA
- 2023-01-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.