July 2021 FDA Recall Drug by Teligent Pharma, Inc.
D-0769-2021 - Defective container

This Class II 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 defective container. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0769-2021

Reason for Recall
Defective container: possibility for lack of seal integrity.
Initiated
07-29-2021
Reported
09-01-2021
Quantity
7488 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88377
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.
Ongoing
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.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

Batch or Lot Expiration Information

Lot# : 14892, Exp 1/2022