Recall: D-0712-2018

Class II - Potentially Harmful

Class IIClassification

2018-04-13Initiated

TerminatedStatus

Lyne Laboratories, Inc.Firm

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

Distribution

to be entered

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.