D-0680-2022 Class II Terminated
FDA drug recall D-0680-2022 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: 36,018 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
- 36,018 bottles
Product Description
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
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: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp. 12/31/2023; 16342, 16343, Exp. 1/31/2024; 16503, 16504, Exp. 3/31/2024; 16632, Exp. 4/30/2024; 16715, 16731, Exp. 5/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0680-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026