August 2013 FDA Recall Drug by Watson Laboratories Inc
D-1061-2013 - Defective Container

This Class III drug recall was voluntarily initiated by Watson Laboratories Inc on August 30, 2013 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1061-2013

Reason for Recall
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Initiated
08-30-2013
Reported
09-25-2013
Quantity
875 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66169
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
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.
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.

Batch or Lot Expiration Information

Lot# Lot 706224A and 706225A, Exp. 04/15.