Recalls / Class II

Class IID-0153-2023

Product

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

Affected lot / code info

Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023

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

267,678 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-0153-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.