D-0647-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2020
- Initiation Date
- November 15, 2019
- Termination Date
- August 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,206 boxes
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot V20M54A, Exp 01/2021