March 2021 FDA Recall Drug by Teligent Pharma, Inc.
D-0331-2021 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Teligent Pharma, Inc. on March 29, 2021 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0331-2021

Reason for Recall
Failed Stability Specifications: product did not meet viscosity results.
Initiated
03-29-2021
Reported
04-21-2021
Quantity
62,040 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87631
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-03-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

Batch or Lot Expiration Information

Lot# Lot 13269, Exp March 2021