FDA Drug recall D-0653-2017
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gav…
- FDA Drug
- Class III
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class III recall of Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gav… by Novel Laboratories, citing chemical Contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0653-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-02-22 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novel Laboratories |
| Distribution | US |
Product
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Reason
Chemical Contamination
Identifiers
| ndc | 43386-069-60 |
|---|---|
| code_info | Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.