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.

Recall Number: D-0839-2020

Firm: Akorn Inc

Classification: Class II

Status: Terminated

Report Date: 20200219

Initiation Date: 20191216

Termination Date: 20220729

Reason for Recall

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

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.