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

Recall Number: D-0712-2018

Firm: Lyne Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20180502

Initiation Date: 20180413

Termination Date: 20190516

Subpotent Drug

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