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Class II · ModerateRecall completed

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch 07319032A1, Exp 02/2021
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAurolife Pharma, LLC
Brand nameDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Generic nameDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Active ingredient(s)AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE
Distributed by / forAurobindo Pharma USA Inc., Dayton, NJ 08810
NDC13107-073-01
Show the full FDA record
Full product labelDextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the US
Quantity11,129 100-count bottles
Recall initiated2019-09-19
Report date2019-10-23
Recall completed2023-04-04
Recall numberD-0143-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.