Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Tablet
FDA Recall NDC 0555-0776
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 8 recorded enforcement report(s) associated with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 0555-0776). A significant event, classified as Class II, was initiated on Aug 29, 2022 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product."
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
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Aug 29, 2022
Sep 21, 2022
83,703 bottles
Recall Profile & Regulatory Data
Event ID
90803
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US.
Termination Date
Aug 14, 2023
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.
Batch or Lot Expiration Information
Lot# : 100023340, Exp 10/2024
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
May 2020 Class II Recall: Some bottles may contain mixed strengths of the product.
Recall Number
Class II Terminated
Some bottles may contain mixed strengths of the product.
May 22, 2020
Jun 10, 2020
41,348 bottles
Recall Profile & Regulatory Data
Event ID
85712
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United State and Puerto Rico.
Termination Date
May 25, 2021
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02
Batch or Lot Expiration Information
Lot# : 42617008, Exp. date 10/2021
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
May 2020 Class II Recall: Some bottles may contain mixed strengths of the product.
Recall Number
Class II Terminated
Some bottles may contain mixed strengths of the product.
May 22, 2020
Jun 10, 2020
33,280 bottles
Recall Profile & Regulatory Data
Event ID
85712
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United State and Puerto Rico.
Termination Date
May 25, 2021
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
Batch or Lot Expiration Information
Lot# : 42614718, Exp. date 02/2021
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
May 2020 Class II Recall: Some bottles may contain mixed strengths of the product.
Recall Number
Class II Terminated
Some bottles may contain mixed strengths of the product.
May 22, 2020
Jun 10, 2020
84,209 bottles
Recall Profile & Regulatory Data
Event ID
85712
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United State and Puerto Rico.
Termination Date
May 25, 2021
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02
Batch or Lot Expiration Information
Lot# : 42617891, exp. date 01/2022
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
November 2015 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Nov 12, 2015
Jan 20, 2016
9,717 bottles
Recall Profile & Regulatory Data
Event ID
72988
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 01, 2016
Product Description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Batch or Lot Expiration Information
Lot# : 34015516A, Exp 05/16
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
Class II Terminated
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Jun 24, 2015
Aug 12, 2015
19,504 bottles
Recall Profile & Regulatory Data
Event ID
71594
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 17, 2016
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
Batch or Lot Expiration Information
Lot# : 34015862A, Exp. Date 6/2016
Lot# : 34016376A, Exp. Date 7/2016
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
October 2014 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Oct 08, 2014
Nov 05, 2014
19,545 Bottles
Recall Profile & Regulatory Data
Event ID
69483
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Termination Date
Sep 21, 2015
Product Description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
Batch or Lot Expiration Information
Lot# : 34016373A, Expiry: 7/2016
Lot# : 34016377A, Expiry: 7/2016.
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
Class II Terminated
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Jan 24, 2014
Mar 12, 2014
9796 tablets
Recall Profile & Regulatory Data
Event ID
67412
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 08, 2014
Product Description
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Batch or Lot Expiration Information
Lot# 34017575A, Exp. 10/16.
Affected Packages Involved in this Recall
0555-0971-02Product
0555-0775-02Product
0555-0972-02Product
0555-0776-02Product
0555-0777-02Product
0555-0973-02Product
0555-0974-02Product
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.
