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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Recall Number D-1402-2012
Classification Class III
Code Info Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
Product Distributed Qty 18,902 bottles
Reason For Recall Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Event Detail

Event Id 62383
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories Inc
City Corona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide