Medications & Supplements/Topical Products

G & W Laboratories, Inc.: Ciclopirox Olamine Cream Recalled for Yellow Discoloration

Agency Publication Date: February 2, 2018

Summary

G & W Laboratories, Inc. has recalled 142,236 tubes of Ciclopirox Olamine Cream USP, 0.77%, a prescription topical medication used to treat fungal skin infections. The recall was initiated because the product, which should be a consistent white to off-white cream, may show intermittent yellow discoloration. This discoloration indicates the product does not meet its physical quality standards, and the affected tubes were distributed nationwide across the United States and Puerto Rico.

Risk

While the risk level is considered low, the yellow discoloration indicates the cream has deviated from its intended physical appearance, which could potentially impact the consistency or quality of the medication.

What You Should Do

Identify if you have the affected Ciclopirox Olamine Cream USP, 0.77%, by checking the tube size: 15 g (NDC 0713-0638-15), 30 g (NDC 0713-0638-31), or 90 g (NDC 0713-0638-18).
Check the lot numbers and expiration dates on the tube or outer carton. Affected 15 g lots are 1002896 (Exp 09/18), 1005797 (Exp 05/19), and 1006100 (Exp 07/19).
Check 30 g tubes for lot numbers 1002561 (Exp 06/18), 1002897 (Exp 09/18), 1005798 (Exp 05/19), and 1006101 (Exp 07/19).
Check 90 g tubes for lot numbers 1002898 (Exp 10/18), 1004283 (Exp 12/18), 1005837 (Exp 05/19), 1006321 (Exp 07/19), and 1006322 (Exp 07/19).
Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication and to obtain a replacement if necessary.
Return any unused or discolored product to your pharmacy to request a refund.
Contact G & W Laboratories, Inc. at their South Plainfield, NJ location for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ciclopirox Olamine Cream USP, 0.77% (15 g tube)

Model:

NDC 0713-0638-15

Lot Numbers:

1002896 (Exp 09/18)

1005797 (Exp 05/19)

1006100 (Exp 07/19)

Date Ranges: 09/18, 05/19, 07/19

Product: Ciclopirox Olamine Cream USP, 0.77% (30 g tube)

Model:

NDC 0713-0638-31

Lot Numbers:

1002561 (Exp 06/18)

1002897 (Exp 09/18)

1005798 (Exp 05/19)

1006101 (Exp 07/19)

Date Ranges: 06/18, 09/18, 05/19, 07/19

Product: Ciclopirox Olamine Cream USP, 0.77% (90 g tube)

Model:

NDC 0713-0638-18

Lot Numbers:

1002898 (Exp 10/18)

1004283 (Exp 12/18)

1005837 (Exp 05/19)

1006321 (Exp 07/19)

1006322 (Exp 07/19)

Date Ranges: 10/18, 12/18, 05/19, 07/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78974

Status: Resolved

Manufacturer: G & W Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 142,236 tubes

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Ciclopirox Olamine Cream USP, 0.77%, by checking the tube size: 15 g (NDC 0713-0638-15), 30 g (NDC 0713-0638-31), or 90 g (NDC 0713-0638-18).

Check the lot numbers and expiration dates on the tube or outer carton. Affected 15 g lots are 1002896 (Exp 09/18), 1005797 (Exp 05/19), and 1006100 (Exp 07/19).

Check 30 g tubes for lot numbers 1002561 (Exp 06/18), 1002897 (Exp 09/18), 1005798 (Exp 05/19), and 1006101 (Exp 07/19).

Check 90 g tubes for lot numbers 1002898 (Exp 10/18), 1004283 (Exp 12/18), 1005837 (Exp 05/19), 1006321 (Exp 07/19), and 1006322 (Exp 07/19).

Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication and to obtain a replacement if necessary.

Return any unused or discolored product to your pharmacy to request a refund.

Contact G & W Laboratories, Inc. at their South Plainfield, NJ location for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Ciclopirox Olamine Cream USP, 0.77% (15 g tube)

Model:

NDC 0713-0638-15

Lot Numbers:

1002896 (Exp 09/18)

1005797 (Exp 05/19)

1006100 (Exp 07/19)

Date Ranges: 09/18, 05/19, 07/19

Product: Ciclopirox Olamine Cream USP, 0.77% (30 g tube)

Model:

NDC 0713-0638-31

Lot Numbers:

1002561 (Exp 06/18)

1002897 (Exp 09/18)

1005798 (Exp 05/19)

1006101 (Exp 07/19)

Date Ranges: 06/18, 09/18, 05/19, 07/19

Product: Ciclopirox Olamine Cream USP, 0.77% (90 g tube)

Model:

NDC 0713-0638-18

Lot Numbers:

1002898 (Exp 10/18)

1004283 (Exp 12/18)

1005837 (Exp 05/19)

1006321 (Exp 07/19)

1006322 (Exp 07/19)

Date Ranges: 10/18, 12/18, 05/19, 07/19