Bexarotene Capsule
FDA Recall NDC 0832-0285
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bexarotene (NDC 0832-0285). A significant event, classified as Class II, was initiated on Jul 29, 2019 by Upsher-smith Laboratories, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications
Jul 29, 2019
Aug 28, 2019
166 bottles
Recall Profile & Regulatory Data
Event ID
83501
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Upsher Smith Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
KY, OH, NJ, LA
Termination Date
Aug 25, 2022
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
Batch or Lot Expiration Information
Lot# Lot: A2610. exp 3/2020
Affected Packages Involved in this Recall
0832-0285-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
