Drug product
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
D-1392-2019
Product summary
- Firm
- Akorn Inc
- Event
- Event 83073
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,216 cartons
- Official record key
drug-enforcement:D-1392-2019
Official wording
Reason: Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Code information: Lot#: V30M56A, Exp 9/20
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up