Drug Enforcement D-66251-001

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Status

Terminated

Classification

Class II

Report Date

October 9, 2013

Termination Date

July 25, 2014

Product Information

Product description
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
Product quantity
10,615 bottles
Reason for recall
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
132 Business Center Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-66251-001
Event ID
66251
Recall initiation date
September 13, 2013
Center classification date
October 3, 2013
Code info
Lot #: 705791A, Exp 04/2015
More code info