FDA recall D-66251-001

Watson Laboratories Inc · Class II · drug

Product

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

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-09-13
Report date: 2013-10-09
Termination date: 2014-07-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66251-001