September 2020 FDA Recall Drug by Teligent Pharma, Inc.
D-0064-2021 - Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

This Class III drug recall was voluntarily initiated by Teligent Pharma, Inc. on September 28, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation - out-of-specification results for fluocinolone acetonide impurity.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0064-2021

Reason for Recall
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Initiated
09-28-2020
Reported
11-11-2020
Quantity
36,790 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86508
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teligent Pharma, 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.
United States Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-22-2022
Product Description About Product Description
Full technical description of the product.
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

Batch or Lot Expiration Information

Lot# : a) 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022; b) 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022; c) 12241, 12249, Exp 10/2020; 14222, Exp 8/2021; 15039, Exp 1/2022; 15037, 15246, Exp 2/2022; 15340, Exp 3/2022; 15387, Exp 4/2022