FDAClass IIIApril 19, 2017

Fluocinolone Acetonide Topical Solution USP 0.01% For recall: Contamination

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis…

Why was Fluocinolone Acetonide Topical Solution USP 0.01% For recalled?

Chemical Contamination

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17

Product
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis…
Recalling firm
Novel Laboratories, Inc.
Quantity
7,656 bottles
Distribution
Nationwide
Recall date
April 19, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls