Teligent Pharma, Inc.: Drug Recall

Recall #D-0297-2022 · 08/23/2021

Class II: Risk

Recall Details

Recall Number: D-0297-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teligent Pharma, Inc.
Status: Terminated
Date Initiated: 08/23/2021
Location: Buena, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,792 bottles

Reason for Recall

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

Product Description

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Distribution Pattern

Distributed Nationwide in the USA

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.