Home / Recalls / ANI Pharmaceuticals, Inc. / D-0048-2021

D-0048-2021 Class III Terminated

Recalled by ANI Pharmaceuticals, Inc. — Baudette, MN

Recall Details

Product Type
Drugs
Report Date
October 28, 2020
Initiation Date
October 9, 2020
Termination Date
January 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34968 bottles

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

Reason for Recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022

Other recalls by ANI Pharmaceuticals, Inc.

  • D-0565-2022 Class II — Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901- (February 15, 2022)
  • D-0568-2022 Class II — Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: U (February 15, 2022)
  • D-0564-2022 Class II — Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900 (February 15, 2022)
  • D-0566-2022 Class II — Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902- (February 15, 2022)
  • D-0567-2022 Class II — Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903- (February 15, 2022)
  • D-0044-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0047-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0046-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0043-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0045-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)