Why it was recalled
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Product description
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Lot numbers, UPCs & expiration codes
Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
Where it was sold
Nationwide in the USA and Puerto Rico
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-0250-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 19, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- 142,236 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0250-2018, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78974
- Address
- 200 Helen St
- Code information
- Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
- Postal code
- 07080-3800
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0250-2018
- Classification
- Class III
- Recalling firm
- G & W Laboratories, Inc.
- Product quantity
- 142,236 tubes
- Termination date
- Feb 3, 2020
- Reason for recall
- Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jan 19, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 2, 2018