Xanax Tablet
FDA Recall NDC 0009-0055
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 Xanax (NDC 0009-0055). A significant event, classified as Class II, was initiated on Sep 24, 2015 by Pharmacia & Upjohn Company Llc. The reported reason for this action was: "Subpotent Drug"
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
Subpotent Drug
Sep 24, 2015
Nov 04, 2015
21,120 HDPE bottles
Recall Profile & Regulatory Data
Event ID
72199
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 08, 2017
Product Description
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
Batch or Lot Expiration Information
Lot# C111054; Exp. 02/16
Affected Packages Involved in this Recall
0009-0029-01Product
0009-0029-46Product
0009-0029-02Product
0009-0029-14Product
0009-0055-01Product
0009-0055-46Product
0009-0055-03Product
0009-0055-15Product
0009-0090-01Product
0009-0090-04Product
0009-0090-13Product
0009-0094-01Product
0009-0094-03Product
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.
