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

FDA recall notice · announced August 24, 2022 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA
Lot/code information: Lot# 379804, Exp. 8/31/2023
Quantity: 14,712 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-1361-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.