FDA-Drug2018-02-14Class III
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.
G & W Laboratories, Inc.
Hazard
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
142,236 tubes
Manufactured in
200 Helen St, N/A, South Plainfield, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2018Don't want to check this manually?
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