Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Capsule, Extended Release
FDA Recall NDC 43975-280
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 43975-280). A significant event, classified as Class III, was initiated on Oct 09, 2020 by Ani Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months."
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
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
13536 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10
Batch or Lot Expiration Information
Lot# Lot: 19S10 Exp. Sept. 2021, 19S11 Exp. Oct. 2021
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
Class III Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
6780 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10
Batch or Lot Expiration Information
Lot# Lot: 19T16 Exp. Jan. 2022
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
Class III Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
24972 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10
Batch or Lot Expiration Information
Lot# Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
Class III Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
13248 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10
Batch or Lot Expiration Information
Lot# Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
Class III Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
408 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10
Batch or Lot Expiration Information
Lot# Lot: 19S07 Exp. Sept. 2021
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
Class III Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Oct 09, 2020
Oct 28, 2020
34968 bottles
Recall Profile & Regulatory Data
Event ID
86584
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 19, 2022
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10
Batch or Lot Expiration Information
Lot# Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022
Affected Packages Involved in this Recall
43975-277-10Product
43975-278-10Product
43975-279-10Product
43975-280-10Product
43975-282-10Product
43975-281-10Product
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.
