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
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
Mispackaging