Teligent Pharma, Inc.: Drug Recall

Recall #D-0338-2021 · 02/02/2021

Class III: Low Risk

Recall Details

Recall Number: D-0338-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Teligent Pharma, Inc.
Status: Terminated
Date Initiated: 02/02/2021
Location: Buena, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 104,784 tubes

Reason for Recall

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Product Description

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Distribution Pattern

USA 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.