FDAClass IIAugust 24, 2022

PrednisoLONE Oral Solution USP recall

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

Why was PrednisoLONE Oral Solution USP recalled?

Defective Container: Product has incomplete induction seals.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 379804, Exp. 8/31/2023

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
Recalling firm
Akorn, Inc
Quantity
14,712 bottles
Distribution
Nationwide USA
Recall date
August 24, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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