AMPHETAMINE SULFATE

Generic: AMPHETAMINE SULFATE

Epic Pharma LLCManufacturer
ORALRoute
AMPHETAMINE SULFATEActive Substance
2020-10-27Original Approval

AMPHETAMINE SULFATE is FDA application ANDA213980, sponsored by EPIC PHARMA LLC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-05-22
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A

Some bottles may contain mixed strengths of the product.

Class III2025-08-28
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

Failed Impurities/Degradation Specifications:

Class II2020-05-22
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A

Some bottles may contain mixed strengths of the product.

Class II2020-05-22
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A

Some bottles may contain mixed strengths of the product.

Class II2015-11-12
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Sa

Failed Impurities/Degradation Specifications: High out of specification test result for impurities d

Class III2025-08-28
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte

Failed Impurities/Degradation Specifications:

Class II2014-01-24
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII,

CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and A

Class III2020-10-09
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe

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

Class III2020-10-09
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe

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

Class III2020-10-09
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe

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

Top Reported Reactions

1
TOXICITY TO VARIOUS AGENTS
2,179 reports
2
DRUG ABUSE
1,729 reports
3
COMPLETED SUICIDE
824 reports
4
OVERDOSE
450 reports
5
CARDIAC ARREST
397 reports
6
DEATH
390 reports
7
CARDIO-RESPIRATORY ARREST
358 reports
8
RESPIRATORY ARREST
303 reports
9
DRUG INEFFECTIVE
251 reports
10
DRUG INTERACTION
239 reports