Fluocinolone Acetonide Topical Oil — Class II drug recall D-0712-2018
Terminated recall by Lyne Laboratories, Inc., reported 2018-05-02. Subpotent Drug
| Recall number | D-0712-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lyne Laboratories, Inc., Brockton, MA, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-05-16 |
| Quantity | 17,939 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00364980329200 |
| NDC | 64980-0329, 64980-0329-20 |
| Lot numbers | 1604D, FR1604B, FR1604C |
| Expiration dates | 2018-06 |
Product
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200
Reason for recall
Subpotent Drug
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-0712-2018. 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.