Recalls / Class II

Class IID-0141-2023

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.

Affected lot / code info

Lot: (a) 1A09A, EXP 12/31/2022; 1H01A, EXP 7/31/2023 ; (b) 1E32A, EXP 4/30/2023; 1F45A, EXP 5/31/2023; 1H99A, EXP 7/31/2023; 1K84A, EXP 9/30/2023; (c) 0L40A, EXP 10/31/2022; 1B38A, EXP 1/31/2023; 1E12A, EXP 4/30/2023; 1F41A, EXP 5/31/2023; 1G73A, 1G68A, EXP 6/30/2023; 1H08A, 1H12A, 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

314,543 10ml,3ml, 5ml 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-0141-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.