FDA recall D-0636-2017

Product

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 c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.

Reason for recall

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-03-20

Report date

2017-04-12

Termination date

2018-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0636-2017