Home / Recalls / Akorn Inc / D-1392-2019

D-1392-2019 Class III Terminated

Recalled by Akorn Inc — Lake Forest, IL

Recall Details

Product Type: Drugs
Report Date: June 26, 2019
Initiation Date: June 7, 2019
Termination Date: July 28, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,216 cartons

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Lot#: V30M56A, Exp 9/20

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