South Plainfield, NJ, United States
G & W Laboratories, Inc. recalls
1 recall recorded since 2018, most recently on 19 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 19 January 2018
- Terminated
- 3 February 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- 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 Plainfiel
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.