PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: August 24, 2022 Initiated: August 1, 2022 #D-1361-2022

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.

Details

Recalling Firm
Akorn, Inc
Units Affected
14,712 bottles
Distribution
Nationwide USA
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc. Units affected: 14,712 bottles.
Why was this product recalled?
Defective Container: Product has incomplete induction seals.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1361-2022.