PRAMIPEXOLE DIHYDROCHLORIDE

Generic: PRAMIPEXOLE DIHYDROCHLORIDE

Aurobindo Pharma LimitedManufacturer
ORALRoute
PRAMIPEXOLE DIHYDROCHLORIDEActive Substance
2012-10-26Original Approval

PRAMIPEXOLE DIHYDROCHLORIDE is FDA application ANDA202633, sponsored by AUROBINDO PHARMA LTD. 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 III2019-08-21
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plain

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Ta

Class II2015-12-24
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plain

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Top Reported Reactions

1
DRUG INEFFECTIVE
510 reports
2
FATIGUE
350 reports
3
OFF LABEL USE
302 reports
4
HEADACHE
298 reports
5
PAIN
298 reports
6
NAUSEA
292 reports
7
FALL
283 reports
8
INSOMNIA
261 reports
9
CONDITION AGGRAVATED
260 reports
10
PNEUMONIA
253 reports