Loxapine Capsule
FDA Recall NDC 0591-0372
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Loxapine (NDC 0591-0372). A significant event, classified as Class III, was initiated on Apr 17, 2012 by Actavis Pharma, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Apr 17, 2012
Jul 11, 2012
21,572 bottles
Recall Profile & Regulatory Data
Event ID
62383
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Watson Laboratories Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 18, 2013
Product Description
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
Batch or Lot Expiration Information
Lot# s: 101696A, 110829A, 123685A, 123687A
Affected Packages Involved in this Recall
0591-0369-01Product
0591-0370-01Product
0591-0371-01Product
0591-0372-01Product
Class III Terminated
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Apr 17, 2012
Jul 11, 2012
18,902 bottles
Recall Profile & Regulatory Data
Event ID
62383
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Watson Laboratories Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 18, 2013
Product Description
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Batch or Lot Expiration Information
Lot# s: 104432A, 104433A, 121344A, 127024A, 144290A
Affected Packages Involved in this Recall
0591-0369-01Product
0591-0370-01Product
0591-0371-01Product
0591-0372-01Product
Class III Terminated
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Apr 17, 2012
Jul 11, 2012
106,323 bottles
Recall Profile & Regulatory Data
Event ID
62383
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Watson Laboratories Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 18, 2013
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
Batch or Lot Expiration Information
Lot# s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.
Affected Packages Involved in this Recall
0591-0369-01Product
0591-0370-01Product
0591-0371-01Product
0591-0372-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
