Alprazolam Tablet
FDA Recall NDC 0781-1079
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 Alprazolam (NDC 0781-1079). A significant event, classified as Class II, was initiated on Jul 25, 2014 by Sandoz Inc. The reported reason for this action was: "Presence of Foreign Substance; tablets may contain stainless steel metal particulates"
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
July 2014 Class II Recall: Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Recall Number
Class II Terminated
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Jul 25, 2014
Aug 06, 2014
1,332 bottles
Recall Profile & Regulatory Data
Event ID
68900
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz Incorporated
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 05, 2015
Product Description
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Batch or Lot Expiration Information
Lot# Lot EJ9591
Affected Packages Involved in this Recall
0781-1061-01Product
0781-1061-05Product
0781-1061-10Product
0781-1077-01Product
0781-1077-05Product
0781-1077-10Product
0781-1079-01Product
0781-1079-05Product
0781-1079-10Product
0781-1089-01Product
0781-1089-05Product
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.
