D-0673-2022 Class II Terminated
FDA drug recall D-0673-2022 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: 72,826 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
- 72,826 tubes
Product Description
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, 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) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; b) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; 17046, Exp. 6/30/2023; c) 15856, Exp. 8/31/2022; d) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0673-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026