July 2012 FDA Recall Drug by Actavis
D-1693-2012 - Subpotent; some patches may not contain fentanyl gel

This Class II drug recall was voluntarily initiated by Actavis on July 11, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; some patches may not contain fentanyl gel. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1693-2012

Reason for Recall
Subpotent; some patches may not contain fentanyl gel
Initiated
07-11-2012
Reported
10-03-2012
Quantity
98,088 cartons (5 pouches per carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62384
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.
Actavis
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2013
Product Description About Product Description
Full technical description of the product.
Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.

Batch or Lot Expiration Information

Lot# Lot number 455040A (carton) 455040 (pouch)