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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01 Lot # 22478A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. 7,262 bottles D-1403-2012
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01 Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. 18,902 bottles D-1402-2012
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 Lot #s: 101696A, 110829A, 123685A, 123687A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. 21,572 bottles D-1401-2012
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01 Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A. Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. 106,323 bottles D-1400-2012
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. Lot 108094A Class III Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. 8254 bottles D-1399-2012
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