PlainRecalls
FDA Drug Moderate Class II Terminated

Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00

Reported: August 28, 2019 Initiated: July 29, 2019 #D-1836-2019

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

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
166 bottles
Distribution
KY, OH, NJ, LA
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00. Recalled by Upsher Smith Laboratories, Inc.. Units affected: 166 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on August 28, 2019. Severity: Moderate. Recall number: D-1836-2019.