The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0804-2023·Announced 2023-06-07

Fluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns

Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a medication where manufacturing stability could not be verified due to firm closure and incomplete stability studies. While no illnesses have been reported, medications where safety and efficacy cannot be verified represent a risk-of-harm product per the severity rubric.

Plain-English summary

Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg in 16-gram bottles distributed nationwide in the United States and Puerto Rico. The product was manufactured by HI-TECH PHARMACAL CO., INC. All lot numbers are included.

The Food and Drug Administration classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. The recalling company ceased operations and was unable to complete required stability testing. Stability studies are necessary to ensure medications remain safe and effective throughout their shelf life.

Consumers and healthcare providers who have this product should be aware of the recall. Patients with questions should consult their healthcare provider about their current supply.

The recalled product

Product
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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