Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Tablet
FDA Recall NDC 13107-072
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, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 13107-072). A significant event, classified as Class II, was initiated on Sep 19, 2019 by Aurolife Pharma, Llc. The reported reason for this action was: "Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness."
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
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Sep 19, 2019
Oct 23, 2019
11,129 100-count bottles
Recall Profile & Regulatory Data
Event ID
83848
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Apr 04, 2023
Product Description
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
Batch or Lot Expiration Information
Batch# Batch 07319032A1, Exp 02/2021
Affected Packages Involved in this Recall
13107-068-50Product
13107-068-01Product
13107-068-25Product
13107-068-05Product
13107-068-99Product
13107-069-50Product
13107-069-01Product
13107-069-25Product
13107-069-05Product
13107-069-99Product
13107-070-50Product
13107-070-01Product
13107-070-25Product
13107-070-05Product
13107-070-99Product
13107-071-50Product
13107-071-01Product
13107-071-25Product
13107-071-05Product
13107-071-99Product
13107-072-50Product
13107-072-01Product
13107-072-25Product
13107-072-05Product
13107-072-99Product
13107-073-50Product
13107-073-01Product
13107-073-25Product
13107-073-05Product
13107-073-99Product
13107-074-50Product
13107-074-01Product
13107-074-25Product
13107-074-05Product
13107-074-99Product
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.
