Reported Jul 12, 2017 · Terminated

G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC…

G & W Laboratories, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: G & W Laboratories, Inc. · 111 Coolidge St · South Plainfield, NJ · 07080-3895

Is this the product you have?

4 of 4 products

Products covered by this recall
#Product as published
115 g tube (NDC 0713-0656-15)
230 g tube (NDC 0713-0656-31
345 g tube (NDC 0713-0656-37)
460 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
11001090, Exp 8/ 17; 1002881, Exp 2/18
21001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18
31001155, Exp 9/17; 1004572, Exp 7/18
41001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18
Amount recalled
145284 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 9, 2018 · Data as of Sep 19, 5:03 PM UTC

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