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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- ACP Nimble Buyer, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- 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.
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