FDA recall D-0250-2018

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 Plainfield, NJ 07080.

Reason for recall

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-01-19

Report date

2018-02-14

Termination date

2020-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2018