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
| # | Product as published |
|---|---|
| 1 | 15 g tube (NDC 0713-0656-15) |
| 2 | 30 g tube (NDC 0713-0656-31 |
| 3 | 45 g tube (NDC 0713-0656-37) |
| 4 | 60 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 1 1001090, Exp 8/ 17; 1002881, Exp 2/18 2 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18 3 1001155, Exp 9/17; 1004572, Exp 7/18 4 1001158, 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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