Fluticasone Propionate Nasal Spray Recalled Due to Defective Container
Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray nationwide due to a defective container that prevents proper dispensing. Patients should contact their healthcare provider or pharmacist.
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 functional defect in a prescription medication container that prevents proper dispensing, creating a risk of harm to patients who depend on the medication for symptom control. No illnesses or injuries have been reported, which limits the score to a maximum of 3 per the rubric.
Plain-English summary
Akorn, Inc. is recalling Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g bottles (NDC 50383-700-16), manufactured by HI-TECH PHARMACAL CO., INC. This is a prescription nasal spray used to treat allergy and respiratory symptoms.
The recall is due to a defective container that prevents the product from dispensing as intended. This defect could result in patients being unable to obtain proper doses of their medication.
The recall affects approximately 44,400 bottles with lot numbers 379073 and 379079, expiring 9/30/2023, distributed nationwide throughout the United States.
Patients currently using this medication should discontinue use and contact their healthcare provider, pharmacist, or Akorn, Inc. for further instructions. Do not use the product if you have one of the affected lots.
The recalled product
- Product
- Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Nasal Spray
- Affected units
- 44,400
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 (3)
- Lot #: 379073
- 379079
- Exp 9/30/2023
Distribution
Distributed nationwide across the United States.
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