Recalls / Class II
Class IID-1361-2022
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
- Affected lot / code info
- Lot# 379804, Exp. 8/31/2023
Why it was recalled
Defective Container: Product has incomplete induction seals.
Recalling firm
- Firm
- Akorn, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste B, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 14,712 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-08-01
- FDA classified
- 2022-08-19
- Posted by FDA
- 2022-08-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1361-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.