November 2019 FDA Recall Drug by Akorn, Inc.
D-0647-2020 - Unit Dose Mispackaging

This Class II drug recall was voluntarily initiated by Akorn, Inc. on November 15, 2019 for the product Drug. The FDA reported the reason for recall as unit dose mispackaging. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0647-2020

Reason for Recall
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.
Initiated
11-15-2019
Reported
01-08-2020
Quantity
4,206 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84261
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot V20M54A, Exp 01/2021