Home / Recalls / Novel Laboratories, Inc. / D-0653-2017

D-0653-2017 Class III Terminated

Recalled by Novel Laboratories, Inc. — Somerset, NJ

Recall Details

Product Type: Drugs
Report Date: April 19, 2017
Initiation Date: February 22, 2017
Termination Date: August 19, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,656 bottles

Product Description

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

Reason for Recall

Chemical Contamination

Distribution Pattern

Nationwide

Code Information

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