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.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0945-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 2, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 145284 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0945-2017, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77401
- Address
- 111 Coolidge St
- Code information
- 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
- Postal code
- 07080-3895
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0945-2017
- Classification
- Class III
- Recalling firm
- G & W Laboratories, Inc.
- Product quantity
- 145284 tubes
- Termination date
- May 9, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2017