FDA Recall D-0137-2023

Akorn, Inc. · Gurnee, IL

Class II Ongoing 1309 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

Lot / code: Lot: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;

Quantity: 188,550 bottles

Reason for recall

CGMP Deviations:

Recall record

Recall number: D-0137-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2022-10-13
Classified by FDA Center: 2023-01-13
FDA published: 2023-01-25
Recalling firm: Akorn, Inc.
Firm location: Gurnee, IL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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