Medications & Supplements/Topical Products

ACP Nimble Buyer, Inc.: Mometasone Furoate Cream Recalled for Labeling Error

Agency Publication Date: February 20, 2019

Summary

ACP Nimble Buyer, Inc. is recalling 58,176 units of Mometasone Furoate Cream (0.1%), a prescription topical medication used for skin conditions. The recall was issued because of a typographical error on the label regarding the National Drug Code (NDC), which could lead to errors in medication identification or pharmacy processing. This recall affects 45-gram tubes manufactured by G&W Laboratories and distributed nationwide across the United States.

Risk

The typographical error on the product label involves the NDC number, which is a critical identifier for prescription drugs. This error may cause confusion for pharmacists and healthcare providers when dispensing or recording the medication, though it does not impact the safety or efficacy of the cream itself.

What You Should Do

Locate your Mometasone Furoate Cream 0.1% (45 g tube) and check the label for NDC 0713-0726-37.
Check the tube or packaging for the following affected lot numbers and expiration dates: Lot 1009431 (Exp. 08/2020), Lot 1009507 (Exp. 08/2020), or Lot 1009886 (Exp. 09/2020).
Contact your healthcare provider or pharmacist for guidance if you are using a tube from one of the affected lots.
Return any unused product from the affected lots to your pharmacy for a refund.
Contact the manufacturer, ACP Nimble Buyer, Inc., or the distributor at 111 Coolidge St, South Plainfield, New Jersey for further instructions.
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

Drug Recall Refund/Guidance

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

Affected Products

Product: Mometasone Furoate Cream, 0.1% (45 g tube)

Model:

NDC 0713-0726-37

Lot Numbers:

1009431 (Exp. 08/2020)

1009507 (Exp. 08/2020)

1009886 (Exp. 09/2020)

Date Ranges: 08/2020, 09/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80878

Status: Resolved

Manufacturer: ACP Nimble Buyer, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 58,176 units

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

Risk

What You Should Do

Locate your Mometasone Furoate Cream 0.1% (45 g tube) and check the label for NDC 0713-0726-37.

Check the tube or packaging for the following affected lot numbers and expiration dates: Lot 1009431 (Exp. 08/2020), Lot 1009507 (Exp. 08/2020), or Lot 1009886 (Exp. 09/2020).

Contact your healthcare provider or pharmacist for guidance if you are using a tube from one of the affected lots.

Return any unused product from the affected lots to your pharmacy for a refund.

Contact the manufacturer, ACP Nimble Buyer, Inc., or the distributor at 111 Coolidge St, South Plainfield, New Jersey for further instructions.

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