Recalls / Class III
Class IIID-0945-2017
Product
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDC
- 0713-0656
- FDA application
- ANDA074089
- Affected lot / code info
- Lot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18
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.
Recalling firm
- Firm
- G & W Laboratories, Inc.
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 Coolidge St, N/A, South Plainfield, New Jersey 07080-3895
Distribution
- Quantity
- 145284 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-06-02
- FDA classified
- 2017-07-06
- Posted by FDA
- 2017-07-12
- Terminated
- 2018-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0945-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.