Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot V20M54A, Exp 01/2021
Where it was sold
Nationwide in the USA and Puerto Rico
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-0647-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 15, 2019
- FDA report date
- Jan 8, 2020
- Quantity
- 4,206 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0647-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 84261
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot V20M54A, Exp 01/2021
- Postal code
- 60045-4862
- Report date
- Jan 8, 2020
- Product type
- Drugs
- Recall number
- D-0647-2020
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 4,206 boxes
- Termination date
- Aug 9, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Nov 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2020