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.
Reported: February 14, 2018 Initiated: January 19, 2018 #D-0250-2018
Product Description
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.
Details
- Recalling Firm
- G & W Laboratories, Inc.
- Units Affected
- 142,236 tubes
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- South Plainfield, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by G & W Laboratories, Inc.. Units affected: 142,236 tubes.
Why was this product recalled? ▼
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Low. Recall number: D-0250-2018.
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