FDAFDA · Food and drugs·Recall number D-0250-2018
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.
Published February 14, 2018 · Recall initiated: January 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- CICLOPIROX OLAMINE
- Manufacturer
- G & W Laboratories, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0307130638159
- Lot
- Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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