PlainRecalls
FDA Drug Low Class III Terminated

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Reported: January 8, 2014 Initiated: September 30, 2013 #D-391-2014

Product Description

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Reason for Recall

Failed Content Uniformity Specifications; at the 18 month time point.

Details

Recalling Firm
G & W Laboratories Inc
Units Affected
187,368 metal tubes
Distribution
Nationwide
Location
South Plainfield, NJ

Frequently Asked Questions

What product was recalled?
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080. Recalled by G & W Laboratories Inc. Units affected: 187,368 metal tubes.
Why was this product recalled?
Failed Content Uniformity Specifications; at the 18 month time point.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 8, 2014. Severity: Low. Recall number: D-391-2014.