Class III
Terminated
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
This recall has been terminated (originally issued July 12, 2017).
- Company
- G & W Laboratories Inc
- Recall Initiated
- June 2, 2017
- Posted
- July 12, 2017
- Recall Number
- D-0945-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 145284 tubes
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
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
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