September 2013 FDA Recall Drug by Watson Laboratories Inc
D-66360-001 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Watson Laboratories Inc on September 23, 2013 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-66360-001

Reason for Recall
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Initiated
09-23-2013
Reported
10-16-2013
Quantity
1,002,394 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66360
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.
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.
US. No international. NATIONWIDE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2014
Product Description About Product Description
Full technical description of the product.
Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.

Batch or Lot Expiration Information

Lot# : 580974AA and 580975AA. Exp: 09/14