January 09, 2020
Akorn Inc. is recalling more than 4000 boxes of Myorisan (isotretinoin) capsules, 20 mg. According to the January 8, 2020, US Food and Drug Administration (FDA) Enforcement Report, a customer reported a box labeled for 20-mg capsules contained a blister card of 40-mg capsules.
The recall is for 20-mg Myorisan, 30-count boxes (NDC 61748-302-13) containing three 10-capsule blister cards each, from lot V20M54A (Exp. 1/21). The boxes were distributed throughout the United States and Puerto Rico by VersaPharm Inc., an Akorn company.
Akorn initiated the voluntary recall November 15, 2019. On January 6, 2020, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Myorisan is a vitamin A derivative available with a prescription to treat severe acne.