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Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...

FDA Recall #D-0045-2021 — Class III — October 9, 2020

Recall #D-0045-2021 Date: October 9, 2020 Classification: Class III Status: Terminated

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

Reason for Recall

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

Recalling Firm

ANI Pharmaceuticals, Inc. — Baudette, MN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

13248 bottles

Distribution

Distributed Nationwide in the USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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