July 2018 FDA Recall Fluocinolone Acetonide Topical by Teva Pharmaceuticals Usa
D-0909-2018 - Failed Impurities and Degradation Specifications and Subpotent Drug

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 5, 2018 for the product Fluocinolone Acetonide Topical. The FDA reported the reason for recall as failed impurities and degradation specifications and subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0909-2018

Reason for Recall
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Initiated
07-05-2018
Reported
07-18-2018
Quantity
27,803 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80437
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.

Batch or Lot Expiration Information

Lot# s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20

Affected Packages Involved in this Recall

0591-2990-60 Fluocinolone Acetonide Topical