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FDAFDA · Food and drugs·Recall number D-0653-2017

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

Published April 19, 2017 · Recall initiated: February 22, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Chemical Contamination

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
FLUOCINOLONE ACETONIDE
Manufacturer
Novel Laboratories, Inc.
Distributor
Nationwide
UPC
0343386069606
Lot
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
Risk classification
Class III
Area (FDA)
drug
Country
United States

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