CICLOPIROX OLAMINE

Generic: CICLOPIROX OLAMINE

Glenmark Pharmaceuticals Inc.Manufacturer
TOPICALRoute
CICLOPIROX OLAMINEActive Substance
2009-11-10Original Approval

CICLOPIROX OLAMINE is FDA application ANDA090273, sponsored by GLENMARK PHARMS. 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 III2018-01-19
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermit

Class III2017-03-20
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Top Reported Reactions

1
DRUG INEFFECTIVE
138 reports
2
DEVICE DISLOCATION
78 reports
3
DEVICE MALFUNCTION
78 reports
4
PRODUCT USE IN UNAPPROVED INDICATION
38 reports
5
OFF LABEL USE
25 reports
6
RASH
25 reports
7
FATIGUE
22 reports
8
PRURITUS
21 reports
9
CONDITION AGGRAVATED
17 reports
10
PAIN
17 reports