July 2021 FDA Recall Drug by Teligent Pharma, Inc.
D-0785-2021 - Failed Viscosity Specifications

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

Recall Number: D-0785-2021

Reason for Recall
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Initiated
07-29-2021
Reported
09-08-2021
Quantity
114,456 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88382
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

Batch or Lot Expiration Information

Lot# : 15378, Exp 3/2023; 14418 EXP 10/2021