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Recall Observatory FDA recall evidence

Drug 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

D-1361-2022

August 01, 2022

Class II

Product summary

Firm
Akorn, Inc
Event
Event 90676
Status
Ongoing
Classification
Class II
Quantity
14,712 bottles
Official record key
drug-enforcement:D-1361-2022

Official wording

Reason: Defective Container: Product has incomplete induction seals.

Code information: Lot# 379804, Exp. 8/31/2023

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Product has incomplete induction seals.