D-0695-2022 Class II Terminated
FDA drug recall D-0695-2022 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: 217,184 tubes.
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
- 217,184 tubes
Product Description
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 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) 15125, Exp. 2/28/2022; 15385, Exp. 3/31/2022; 15613, Exp. 5/31/2022; 16027, Exp. 9/30/2022; 16204, Exp. 11/30/2022; 16376, Exp. 1/31/2023; 16707, Exp. 3/31/2023; b) 15385, Exp. 3/31/2022; 15752, Exp. 6/30/2022; 15346, Exp. 9/30/2022; 16188, Exp. 11/30/2022; 16567, Exp. 2/28/2023; 16730, Exp. 4/30/2023; c)15752, Exp. 6/30/2022; 16188, Exp. 11/30/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0695-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026