Teligent Pharma, Inc.: Drug Recall

Recall #D-0636-2021 · 05/14/2021

Class II: Risk

Recall Details

Recall Number: D-0636-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Teligent Pharma, Inc.
Status: Terminated
Date Initiated: 05/14/2021
Location: Buena, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,240 tubes

Reason for Recall

Presence of Foreign Substance: Foreign particles observed during routine stability testing.

Product Description

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.

Distribution Pattern

Nationwide in the United States

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.