FDA Recall D-1361-2022
Akorn, Inc · Gurnee, IL
Class II Ongoing 1382 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Reason for recall
Defective Container: Product has incomplete induction seals.
Recall record
- Recall number
D-1361-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA
- Recall initiated
- 2022-08-01
- Classified by FDA Center
- 2022-08-19
- FDA published
- 2022-08-24
- 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.