Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle,...
FDA Recall #D-058-2013 — Class I — September 21, 2012
Product Description
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.
Reason for Recall
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Recalling Firm
Watson Laboratories Inc — Corona, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
4,874 bottles
Distribution
Nationwide
Code Information
Lot #: 519406A, 521759A, Exp 04/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated