The Recall Desk
LowFDA (Drugs)·D-0514-2019·Announced 2019-02-27

Mometasone Furoate Cream Recalled for NDC Typographical Error

ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error (NDC typo) with no reported injuries or illnesses.

Plain-English summary

ACP Nimble Buyer, Inc. is voluntarily recalling Mometasone Furoate Cream, 0.1%, 45 g tube, manufactured by G&W Laboratories, Inc. The recall is being conducted because of a labeling error identified as a typographical mistake in the National Drug Code (NDC) number.

The affected product is prescription-only and was distributed nationwide within the United States. The recall covers 58,176 units from specific lots with expiration dates in August and September 2020.

Consumers and healthcare providers should check their inventory for the affected NDC number and lot numbers. If the product is found, it should be returned to the supplier or disposed of according to local regulations. No adverse health consequences are expected from this labeling error.

The recalled product

Product
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Affected units
58,176

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #: 1009431
  • 1009507
  • Exp. 08/2020
  • 1009886
  • Exp. 09/2020

Distribution

Distributed nationwide across the United States.