Dextroamphetamine Sulfate Tablet
FDA Recall NDC 0555-0953
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 Dextroamphetamine Sulfate (NDC 0555-0953). A significant event, classified as Class II, was initiated on May 01, 2014 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing."
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
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
May 01, 2014
Jul 02, 2014
9,882 bottles
Recall Profile & Regulatory Data
Event ID
68225
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 09, 2014
Product Description
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Batch or Lot Expiration Information
Lot# 34013122A, Exp 11/15
Affected Packages Involved in this Recall
0555-0952-02Product
0555-0953-02Product
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.
