FDA Drug recall D-0909-2018
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City,…
- FDA Drug
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City,… by Teva Pharmaceuticals Usa, citing failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0909-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-05 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Reason
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Identifiers
| ndc | 0591-2990-60 |
|---|---|
| code_info | Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20 |
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-0909-2018%22
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