FDA Drug recall D-0712-2018
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc by Lyne Laboratories, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0712-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-13 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lyne Laboratories |
| Distribution | n/a |
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
Subpotent Drug
Identifiers
| upc | 364980329200 |
|---|---|
| ndc | 64980-329-20 |
| ndc | 3649803292 |
| code_info | Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018 |
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-0712-2018%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.