April 2015 FDA Recall Drug by Actavis Laboratories
D-0486-2015 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Actavis Laboratories on April 14, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0486-2015

Reason for Recall
Subpotent Drug: Flurandrenolide is subpotent.
Initiated
04-14-2015
Reported
04-22-2015
Quantity
78,522 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70987
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Laboratories
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.
U.S. Nationwide, including Puerto Rico; United Kingdom.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-20-2016
Product Description About Product Description
Full technical description of the product.
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.

Batch or Lot Expiration Information

Lot# A) Lots: 266142A, 843021, 845760, 853846, 893193, 900634; Expiry: JAN-2016. B) Lots: 266142D, 822241, 853847, 862000, 874337, 893209; Expiry: JAN-2016. C) Lot: 266142C; Expiry: JAN-2016.