Akorn, Inc. recalls Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles,…

Recall date

August 21, 2015

Source

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

Recall number

D-0295-2016

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10