FDA Drug recall D-0680-2022
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge,…
- FDA Drug
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge,… by Teligent Pharma, citing cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0680-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-15 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
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
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Identifiers
| code_info | Batch: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp.…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0680-2022%22
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