Teligent Pharma, Inc.: Drug Recall

Recall #D-0690-2021 · 06/22/2021

Class III: Low Risk

Recall Details

Recall Number: D-0690-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Teligent Pharma, Inc.
Status: Terminated
Date Initiated: 06/22/2021
Location: Buena, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,824 tubes

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

Distribution Pattern

Nationwide

Other Recalls by Teligent Pharma, Inc.

Class II: Risk 03/15/2022

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

View all recalls by Teligent Pharma, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.