Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityvil…

Recall date

December 16, 2019

Source

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

Recall number

D-0839-2020

FDA classification

Class II

Brand / firm

Akorn Inc

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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

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 dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.