July 2019 FDA Recall Bexarotene by Upsher Smith Laboratories, Inc.
D-1836-2019 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Upsher Smith Laboratories, Inc. on July 29, 2019 for the product Bexarotene. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in KY, OH, NJ, LA and the recall is currently terminated.
Recall Number: D-1836-2019
Failed Dissolution Specifications
07-29-2019
08-28-2019
166 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Upsher Smith Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
KY, OH, NJ, LA
08-25-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: A2610. exp 3/2020
