FDA recall D-0712-2018

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

Distribution

to be entered

Key facts

Status

Terminated

Initiation date

2018-04-13

Report date

2018-05-02

Termination date

2019-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brockton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0712-2018