PROCHLORPERAZINE MALEATE

Generic: PROCHLORPERAZINE MALEATE

Jubilant Cadista Pharmaceuticals Inc.Manufacturer
ORALRoute
PROCHLORPERAZINE MALEATEActive Substance
1998-02-27Original Approval

PROCHLORPERAZINE MALEATE is FDA application ANDA040268, sponsored by JUBILANT CADISTA. 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 III2022-12-27
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Mary

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

Top Reported Reactions

1
NAUSEA
1,293 reports
2
FATIGUE
1,286 reports
3
DIARRHOEA
968 reports
4
DEATH
699 reports
5
VOMITING
645 reports
6
ASTHENIA
544 reports
7
DECREASED APPETITE
509 reports
8
OFF LABEL USE
451 reports
9
CONSTIPATION
424 reports
10
PAIN
406 reports