Why it was recalled
Defective Container: Product has incomplete induction seals.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 379804, Exp. 8/31/2023
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1361-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 1, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 14,712 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc
Original FDA data
Every field from FDA enforcement report D-1361-2022, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 90676
- Address
- 5605 Centerpoint Ct Ste B
- Code information
- Lot# 379804, Exp. 8/31/2023
- Postal code
- 60031-5278
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1361-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc
- Product quantity
- 14,712 bottles
- Reason for recall
- Defective Container: Product has incomplete induction seals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 1, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2022