September 2012 FDA Recall Drug by Watson Laboratories Inc (D-058-2013 - Superpotent (Multiple Ingredient) Drug)
This Class I drug recall was voluntarily initiated by Watson Laboratories Inc on September 21, 2012 for the product Drug. The FDA reported the reason for recall as superpotent (multiple ingredient) drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-058-2013
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
09-21-2012
11-28-2012
4,874 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-24-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Batch or Lot Expiration Information
Lot# : 519406A, 521759A, Exp 04/14
