Fluocinolone Acetonide Topical Solution USP 0 — Class III drug recall D-0653-2017
Terminated recall by Novel Laboratories, Inc., reported 2017-04-19, distributed nationwide. Chemical Contamination
| Recall number | D-0653-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novel Laboratories, Inc., Somerset, NJ, United States |
| Recall initiated | 2017-02-22 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 7,656 bottles |
| Reason classes | chemical contamination |
| NDC | 43386-0069, 43386-0069-60 |
| Lot numbers | 10/17, 12/17, M15496, M15507 |
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 for recall
Chemical Contamination
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0653-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.