February 2014 FDA Recall Drug by Actavis
D-1088-2014 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Actavis on February 7, 2014 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-1088-2014

Reason for Recall
Subpotent Drug: Drug potency was compromised during shipment.
Initiated
02-07-2014
Reported
03-05-2014
Quantity
38,227 Clamshells

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67457
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
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.
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-05-2014
Product Description About Product Description
Full technical description of the product.
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.

Batch or Lot Expiration Information

Lot# : 514656; Expiry: 03/14