D-0679-2022 Class II Terminated
FDA drug recall D-0679-2022 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: 16,643 bottles.
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
- 16,643 bottles
Product Description
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
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: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0679-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026