Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amity…

Recall date

March 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1011-2019

FDA classification

Class II

Brand / firm

Akorn Inc

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10