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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13 Class III 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. 1,260 bottles D-823-2013
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