October 2018 FDA Recall Fluocinolone Acetonide by Lupin Somerset
D-0092-2019 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Lupin Somerset on October 5, 2018 for the product Fluocinolone Acetonide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0092-2019

Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Initiated
10-05-2018
Reported
10-31-2018
Quantity
2712 60-ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81168
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 SOMERSET
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

Batch or Lot Expiration Information

Lot# M16666, EXP 12/2018

Affected Packages Involved in this Recall

43386-069-60 Fluocinolone Acetonide