Recalls / Class III
Class IIID-1392-2019
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
- Affected lot / code info
- Lot#: V30M56A, Exp 9/20
Why it was recalled
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 16,216 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-06-07
- FDA classified
- 2019-06-17
- Posted by FDA
- 2019-06-26
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1392-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.