FDA Recall D-0792-2023
Akorn, Inc. · Gurnee, IL
Class II Ongoing 1114 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Reason for recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall record
- Recall number
D-0792-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall initiated
- 2023-04-26
- Classified by FDA Center
- 2023-06-01
- FDA published
- 2023-06-07
- 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.