PRASUGREL
Generic: PRASUGREL
Aurobindo Pharma LimitedManufacturer
ORALRoute
PRASUGREL HYDROCHLORIDEActive Substance
2017-10-16Original Approval
PRASUGREL is FDA application ANDA205888, sponsored by AUROBINDO PHARMA. 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 II2025-02-25
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Failed Dissolution Specifications - low dissolution results
Class II2019-10-18
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.SFailed Dissolution Specification: Low out of specification dissolution results.
Class II2026-08-17
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., MorgantoFailed Dissolution Specifications; product failed to meet 18-month stability testing acceptance crit
Class II2025-03-05
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-3Failed Dissolution Specifications
Class II2026-08-21
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due
Top Reported Reactions
1
MYOCARDIAL INFARCTION
175 reports
2
DYSPNOEA
116 reports
3
DRUG INEFFECTIVE
111 reports
4
ACUTE MYOCARDIAL INFARCTION
105 reports
5
DRUG INTERACTION
103 reports
6
NAUSEA
98 reports
7
OFF LABEL USE
96 reports
8
CHEST PAIN
94 reports
9
DIZZINESS
82 reports
10
FATIGUE
75 reports