Recall: D-391-2014

Class III - Minor Violations

Class IIIClassification

2013-09-30Initiated

TerminatedStatus

G & W Laboratories IncFirm

Product

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.