Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0612-2017·Announced 2017-03-29

Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup

Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a significant risk but does not involve a structural defect or reported serious injury.

Plain-English summary

Fougera Pharmaceuticals Inc. is recalling 14,665 tubes of Desonide Ointment, 0.05%, 60 grams, prescription only. The recall involves Lot GC9231 and Lot GC9232, both with an expiration date of 05/2019. The product was distributed nationwide.

The recall was initiated due to a labeling mixup. Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment that are labeled as Ketoconazole Cream. This discrepancy creates a risk of medication error.

Patients and healthcare providers should check their inventory for the affected lots. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Consumers should not use the product if there is any uncertainty regarding the labeling.

The recalled product

Product: Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Manufacturer: Fougera Pharmaceuticals Inc.
Category: Drug — Topical Steroid
Hazard: mis-labeling
medication-error
Affected units: 14,665

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 (2)

Lot GC9231 (exp. 05/2019)
Lot GC9232 (exp. 05/2019)

Distribution

Distributed nationwide across the United States.

Same manufacturer · Fougera Pharmaceuticals Inc.

See all →

Moderate
Fougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns
FDA (Drugs) · 2014-11-19
Low
Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns
FDA (Drugs) · 2014-07-23
Low
Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns
FDA (Drugs) · 2014-07-23
Low
Fougera Recalls Triamcinolone Acetonide Cream Due to Labeling Error
FDA (Drugs) · 2014-03-19
Low
Fougera Recalls Ketoconazole Cream Due to Out-of-Specification Degradants
FDA (Drugs) · 2014-02-05

Same hazard · mis labeling