Why it was recalled
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
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 Plainfeld, NJ 07080.
Lot numbers, UPCs & expiration codes
Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.
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-0636-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 20, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 230,700 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0636-2017, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76767
- Address
- 111 Coolidge St
- Code information
- Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.
- Postal code
- 07080-3895
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0636-2017
- Classification
- Class III
- Recalling firm
- G & W Laboratories, Inc.
- Product quantity
- 230,700 tubes
- Termination date
- Feb 14, 2018
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
- 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 Plainfeld, NJ 07080.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 20, 2017
- Initial firm notification
- Center classification date
- Apr 4, 2017