D-0699-2022 Class II Terminated
FDA drug recall D-0699-2022 was initiated by Teligent Pharma, Inc. on Mar 15, 2022 and is designated Class II. Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. The recall status is terminated (terminated Jun 17, 2024). Affected quantity: 482,003 tubes; 45,583 jars.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 30, 2022
- Initiation Date
- Mar 15, 2022
- Termination Date
- Jun 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 482,003 tubes; 45,583 jars
Product Description
Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Reason for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Batch: a) 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15946, Exp. 9/30/2023; b) 14674, Exp. 11/30/2022; 14760, 14798, Exp. 12/31/2022; 14896, Exp. 1/31/2023; 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15802, 15833, Exp. 7/31/2023; 15872, Exp. 8/31/2023; 15946, Exp. 9/30/2023; 16069, Exp. 10/31/2023; 16199, Exp. 11/30/2023; 16429, Exp. 2/29/2024; 16608, 16712, Exp. 3/31/2024; 17080, Exp. 7/31/2024; c)15065, Exp. 2/28/2023; 15072, Exp. 2/28/2023; 15436, Exp. 3/31/2023; 15810, Exp. 7/31/2023; 15877, Exp. 8/31/2023; 15974, Exp. 9/30/2023; 16045, Exp. 10/31/2023; 16269, Exp. 12/31/2023; 16270, Exp. 12/31/2023; 16566, Exp. 3/31/2024; 16713, Exp. 3/31/2024; 17042, Exp. 6/30/2024; 17068, Exp. 7/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0699-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026