D-1392-2019 Class III Terminated
FDA drug recall D-1392-2019 was initiated by Akorn Inc on June 7, 2019 and is designated Class III. Reason for recall: Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly. The recall status is terminated (terminated July 28, 2022). Affected quantity: 16,216 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2019
- Initiation Date
- June 7, 2019
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,216 cartons
Product Description
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
Reason for Recall
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Distribution Pattern
Nationwide USA
Code Information
Lot#: V30M56A, Exp 9/20