Skip to content
Recall Observatory FDA recall evidence

Drug product

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.

D-0647-2020

November 15, 2019

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 84261
Status
Terminated
Classification
Class II
Quantity
4,206 boxes
Official record key
drug-enforcement:D-0647-2020

Official wording

Reason: 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.

Code information: Lot V20M54A, Exp 01/2021

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mispackaging