Pristiq Tablet, Extended Release
FDA Recall NDC 0008-1222
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pristiq (NDC 0008-1222). A significant event, classified as Class II, was initiated on Apr 16, 2014 by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq."
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
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Apr 16, 2014
Jul 02, 2014
220,761 bottles
Recall Profile & Regulatory Data
Event ID
68001
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Us Pharmaceutical Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 20, 2016
Product Description
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
Batch or Lot Expiration Information
Lot# H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
Affected Packages Involved in this Recall
0008-1211-50Product
0008-1211-01Product
0008-1211-14Product
0008-1211-30Product
0008-1222-01Product
0008-1222-14Product
0008-1222-30Product
0008-1222-50Product
0008-1210-30Product
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.
