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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
Recall Number D-823-2013
Classification Class III
Code Info Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
Product Distributed Qty 1,260 bottles
Reason For Recall Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Event Detail

Event Id 65747
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories Inc
City Corona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide