February 2020 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0866-2020 - Failed Impurities/Degradation Specification; high out of specification results observed

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 19, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification; high out of specification results observed. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0866-2020

Reason for Recall
Failed Impurities/Degradation Specification; high out of specification results observed
Initiated
02-19-2020
Reported
03-11-2020
Quantity
876 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85015
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-03-2021
Product Description About Product Description
Full technical description of the product.
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

Batch or Lot Expiration Information

Lot# K800475 exp. date May 2020 K800477 exp. date June 2020