Why it was recalled
Failed Dissolution Specifications
Product description
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Lot numbers, UPCs & expiration codes
Lot: A2610. exp 3/2020
Where it was sold
KY, OH, NJ, LA
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-1836-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2019
- FDA report date
- Aug 28, 2019
- Quantity
- 166 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Upsher Smith Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1836-2019, exactly as published.
Show all FDA fields
- City
- Maple Grove
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 83501
- Address
- 6701 Evenstad Dr N
- Code information
- Lot: A2610. exp 3/2020
- Postal code
- 55369-6026
- Report date
- Aug 28, 2019
- Product type
- Drugs
- Recall number
- D-1836-2019
- Classification
- Class II
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Product quantity
- 166 bottles
- Termination date
- Aug 25, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
- Distribution pattern
- KY, OH, NJ, LA
- Recall initiation date
- Jul 29, 2019
- Initial firm notification
- Telephone
- Center classification date
- Aug 19, 2019