Dextroamphetamine Sulfate Capsule, Extended Release
FDA Recall NDC 45963-305
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dextroamphetamine Sulfate (NDC 45963-305). A significant event, classified as Class II, was initiated on Jul 11, 2016 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
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 Dissolution Specifications
Jul 11, 2016
Aug 03, 2016
8,062 units
Recall Profile & Regulatory Data
Event ID
74713
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 16, 2017
Product Description
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
Batch or Lot Expiration Information
Lot# : 3803J141, Exp. 7/2016
Affected Packages Involved in this Recall
45963-303-09Product
45963-304-09Product
45963-305-09Product
Class II Terminated
Failed Dissolution Specifications
Feb 10, 2015
Mar 11, 2015
42 bottles
Recall Profile & Regulatory Data
Event ID
70522
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 14, 2015
Product Description
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Batch or Lot Expiration Information
Lot# : 2020E141, Exp 07/15
Affected Packages Involved in this Recall
45963-303-09Product
45963-304-09Product
45963-305-09Product
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.
