December 2012 FDA Recall Drug by Watson Laboratories Inc
D-094-2013 - Impurities/Degradation Products

This Class III drug recall was voluntarily initiated by Watson Laboratories Inc on December 13, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-094-2013

Reason for Recall
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Initiated
12-13-2012
Reported
12-26-2012
Quantity
63,627 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63906
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.
Watson Laboratories Inc
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.
12-04-2013
Product Description About Product Description
Full technical description of the product.
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

Batch or Lot Expiration Information

Lot# 432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13