Drug recall D-0045-2021

Class III Terminated reported Oct 28, 2020

Product

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

Reason for recall

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

Lots and codes

Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022

Recall details

Recalling firm
ANI Pharmaceuticals, Inc., Baudette, MN
Quantity
13248 bottles
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 9, 2020
Terminated
January 19, 2022

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