Teligent Pharma, Inc.: Drug Recall

Recall #D-0682-2022 · 03/15/2022

Class II: Risk

Recall Details

Recall Number: D-0682-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teligent Pharma, Inc.
Status: Terminated
Date Initiated: 03/15/2022
Location: Buena, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 151,975 tubes

Reason for Recall

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

Product Description

Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

Distribution Pattern

Nationwide in the USA and Puerto Rico

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.