Why it was recalled
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
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
Lot numbers, UPCs & expiration codes
Lot#: V30M56A, Exp 9/20
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1392-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 7, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 16,216 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-1392-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83073
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot#: V30M56A, Exp 9/20
- Postal code
- 60045-4862
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1392-2019
- Classification
- Class III
- Recalling firm
- Akorn Inc
- Product quantity
- 16,216 cartons
- Termination date
- Jul 28, 2022
- Reason for recall
- Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jun 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2019