Paxil
FDA Recall NDC 60505-3669
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Paxil (NDC 60505-3669). A significant event, classified as Class II, was initiated on Mar 24, 2014 by Apotex Corp. The reported reason for this action was: "Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents."
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
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Mar 24, 2014
Sep 10, 2014
N/A
Recall Profile & Regulatory Data
Event ID
68967
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 23, 2014
Product Description
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3
Batch or Lot Expiration Information
Lot# 2E001; Exp. 05/15
Affected Packages Involved in this Recall
60505-4377-3Product
60505-4378-3Product
60505-4379-3Product
60505-3668-3Product
60505-3669-3Product
60505-3670-3Product
Class II Terminated
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Mar 24, 2014
Sep 10, 2014
N/A
Recall Profile & Regulatory Data
Event ID
68967
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 23, 2014
Product Description
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3
Batch or Lot Expiration Information
Lot# 2F004, Exp. 06/15
Affected Packages Involved in this Recall
60505-4377-3Product
60505-4378-3Product
60505-4379-3Product
60505-3668-3Product
60505-3669-3Product
60505-3670-3Product
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.
