February 2017 FDA Recall Fluocinolone Acetonide by Novel Laboratories, Inc.
D-0653-2017 - Chemical Contamination
This Class III drug recall was voluntarily initiated by Novel Laboratories, Inc. on February 22, 2017 for the product Fluocinolone Acetonide. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0653-2017
Chemical Contamination
02-22-2017
04-19-2017
7,656 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novel Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-19-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# M15496; Exp. 10/17
Lot# M15507; Exp. 12/17
