Akorn, Inc. recalls MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only…

Recall date

November 15, 2019

Source

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

Recall number

D-0647-2020

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg 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

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.