Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Capsule, Extended Release
FDA Recall NDC 0228-3063
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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (NDC 0228-3063). A significant event, classified as Class III, was initiated on Feb 13, 2013 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met."
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 III Terminated
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Feb 13, 2013
Mar 13, 2013
9,264 Bottles
Recall Profile & Regulatory Data
Event ID
64506
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 06, 2014
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Batch or Lot Expiration Information
Lot# : 50077231
Affected Packages Involved in this Recall
0228-3062-11Product
0228-3059-11Product
0228-3063-11Product
0228-3060-11Product
0228-3064-11Product
0228-3061-11Product
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.
