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PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., IN...

FDA Recall #D-1361-2022 — Class II — August 1, 2022

Recall #D-1361-2022 Date: August 1, 2022 Classification: Class II Status: Ongoing

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

Reason for Recall

Defective Container: Product has incomplete induction seals.

Recalling Firm

Akorn, Inc — Gurnee, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

14,712 bottles

Distribution

Nationwide USA

Code Information

Lot# 379804, Exp. 8/31/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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