The Recall Desk
ModerateFDA (Drugs)·D-0010-2023·Announced 2022-10-26

FDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities

Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution nationwide because the product contains impurities that exceed acceptable limits. The recall affects two lots distributed across the United States.

What this means for you

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: This is an FDA Class II recall for a quality-control issue (out-of-specification impurities) with no reported hospitalizations, illnesses, or injuries. The hazard is precautionary in nature, consistent with a moderate-severity contamination recall.

Plain-English summary

Ingenus Pharmaceuticals LLC is recalling Flunisolide Nasal Solution, USP 0.025% (25 mL bottles) nationwide. The recall is due to the product being out of specification for related substances, meaning it contains impurities that exceed acceptable limits.

The affected lots are #22E040 (Exp. 07/2023) and #22F038 (Exp. 08/2023). A total of 6,176 bottles were distributed nationwide within the United States. The product is identified by NDC 50742-317-25.

This is a Class II recall issued by the FDA.

The recalled product

Product
FLUNISOLIDE (FLUNISOLIDE)
Brand
FLUNISOLIDE
Manufacturer
Ingenus Pharmaceuticals Llc
Category
Drug — Nasal Solution
Hazard
Affected units
6,176

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 (2)

  • Lot #: 22E040 Exp. 07/2023
  • 22F038 Exp. 08/2023

UPCs (1)

  • 350742317257

Distribution

Distributed nationwide across the United States.

Related recalls

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