Recalls / Class II
Class IID-1836-2019
Product
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
- Brand name
- Bexarotene
- Generic name
- Bexarotene
- Active ingredient
- Bexarotene
- Route
- Oral
- NDC
- 0832-0285
- FDA application
- ANDA209886
- Affected lot / code info
- Lot: A2610. exp 3/2020
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Upsher Smith Laboratories, Inc.
- Manufacturer
- Upsher-Smith Laboratories, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6701 Evenstad Dr N, N/A, Maple Grove, Minnesota 55369-6026
Distribution
- Quantity
- 166 bottles
- Distribution pattern
- KY, OH, NJ, LA
Timeline
- Recall initiated
- 2019-07-29
- FDA classified
- 2019-08-19
- Posted by FDA
- 2019-08-28
- Terminated
- 2022-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1836-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.