Home / Recalls / Akorn Inc / D-0839-2020

D-0839-2020 Class II Terminated

Recalled by Akorn Inc — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
February 19, 2020
Initiation Date
December 16, 2019
Termination Date
July 29, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,078 bottles

Product Description

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

Reason for Recall

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 364667, Exp 12/20/2019

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