FDA recall D-1392-2019

Akorn Inc · Class III · drug

Product

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

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2019-06-07
Report date: 2019-06-26
Termination date: 2022-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1392-2019