CICLOPIROX

Generic: CICLOPIROX

Chartwell RXManufacturer

TOPICALRoute

CICLOPIROXActive Substance

2007-09-18Original Approval

CICLOPIROX is FDA application ANDA078046, sponsored by CHARTWELL RX. 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 III2019-02-13

Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI

Failed Degradation/Impurities Specifications: Out of specification related substance results during

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 III2013-10-16

Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L

Subpotent. drug

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Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.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

446 reports

2

FATIGUE

181 reports

3

PAIN

170 reports

4

DIARRHOEA

147 reports

5

PRURITUS

135 reports

6

RASH

135 reports

7

OFF LABEL USE

134 reports

8

HEADACHE

133 reports

9

DYSPNOEA

115 reports

10

NAUSEA

112 reports