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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, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Recall Number D-1400-2012
Classification Class III
Code Info Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
Product Distributed Qty 106,323 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Reason For Recall Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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