Hydroxyzine Pamoate Capsule
FDA Recall NDC 0555-0302
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Hydroxyzine Pamoate (NDC 0555-0302). A significant event, classified as Class II, was initiated on Jan 24, 2014 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing."
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 II Terminated
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Jan 24, 2014
Mar 12, 2014
2494 capsules
Recall Profile & Regulatory Data
Event ID
67412
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 08, 2014
Product Description
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
Batch or Lot Expiration Information
Lot# 34017426A, Exp. 10/16.
Affected Packages Involved in this Recall
0555-0323-02Product
0555-0323-04Product
0555-0302-02Product
0555-0302-04Product
0555-0324-02Product
Class II Terminated
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Jan 24, 2014
Mar 12, 2014
35746 capsules
Recall Profile & Regulatory Data
Event ID
67412
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 08, 2014
Product Description
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
Batch or Lot Expiration Information
Lot# 34016752A, Exp. 09/16.
Lot# 34016753A, Exp. 09/16.
Affected Packages Involved in this Recall
0555-0323-02Product
0555-0323-04Product
0555-0302-02Product
0555-0302-04Product
0555-0324-02Product
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.
