FDAClass IIIOctober 28, 2020

Dextroamphetamine Saccharate recall: Labeling Error

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity…

Why was Dextroamphetamine Saccharate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 19T16 Exp. Jan. 2022

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity…
Recalling firm
ANI Pharmaceuticals, Inc.
Quantity
6780 bottles
Distribution
Distributed Nationwide in the USA
Recall date
October 28, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls