FDA recall D-0141-2023

Akorn, Inc. · Class II · drug

Product

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Reason for recall

CGMP Deviations:

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2022-10-13
Report date: 2023-01-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2023