Recalls / Class II
Class IID-0148-2023
Product
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
- Affected lot / code info
- Lot: 1L03A, EXP 10/31/2023
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
- 1,752 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-0148-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.