Akorn, Inc. recalls Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 300…

Recall date

March 9, 2018

Source

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

Recall number

D-0617-2018

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

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

What was recalled

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.