G & W Clobetasol Propionate Ointment 0.05% recall: Impurity Out of Spec
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
Why was G & W Clobetasol Propionate Ointment 0.05% 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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
- Recalling firm
- G & W Laboratories, Inc.
- Quantity
- 145284 tubes
- Distribution
- Nationwide
- Recall date
- July 12, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)