May 2021 FDA Recall Drug by Teligent Pharma, Inc.
D-0636-2021 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Teligent Pharma, Inc. on May 14, 2021 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0636-2021

Reason for Recall
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Initiated
05-14-2021
Reported
06-30-2021
Quantity
6,240 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87950
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.
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.
Nationwide in the United States
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.
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.

Batch or Lot Expiration Information

Lot# : 16264, Exp Date Nov 2022