Akorn Inc recalls Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs,…

Recall date

June 7, 2019

Source

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

Recall number

D-1392-2019

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

Nationwide USA

Why it was recalled

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

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

What was recalled

Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13