The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0327-2021·Announced 2021-04-14

Cosette Recalls Mometasone Furoate Topical Solution Due to CGMP Deviations

Cosette Pharmaceuticals is recalling specific lots of Mometasone Furoate Topical Solution due to Current Good Manufacturing Practice (CGMP) deviations.

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 due to CGMP deviations. Per the rubric, this falls under 'voluntary precautionary recalls' or minor issues where the probability of serious adverse health consequences is remote, aligning with a Moderate severity score.

Plain-English summary

Cosette Pharmaceuticals, Inc. is voluntarily recalling specific lots of Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion). The affected products are distributed in 30 mL and 60 mL bottles and are prescription-only. The recall was initiated on March 25, 2021, and the status is now Terminated.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The agency classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected lots are: 30 mL bottles with lot numbers 1014611 and 1014612 (expiration 12/2022) and 60 mL bottles with lot numbers 1014593, 1014594, and 1014595 (expiration 10/2022). A total of 7,724 bottles of the 30 mL size and 8,064 bottles of the 60 mL size were distributed nationwide in the US. Consumers should check their medication for these specific lot numbers and expiration dates. If they possess these products, they should contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Manufacturer
Cosette Pharmaceuticals, Inc.
Category
Drug — Topical Steroid
Hazard

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 (4)

  • a) 30 mL: 1014611 and 1014612
  • exp 12/2022 b) 60 mL:1014593
  • 1014594 and 1014595
  • exp 10/2022

Distribution

Distributed nationwide across the United States.

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