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.
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