Akorn Recalls Fluticasone Nasal Spray Due to Preservative Failure
Akorn, Inc. is recalling Fluticasone Propionate Nasal Spray because the preservative benazalkonium chloride failed to meet stability specifications.
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, and the hazard involves a preservative failure without reported illnesses or injuries, fitting the criteria for a moderate severity rating.
Plain-English summary
Akorn, Inc. is recalling 44,448 bottles of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray. The product is packaged in amber glass bottles with a net fill weight of 16 g and provides 120 actuations. The specific lot number is 631639, with an expiration date of 01/2017.
The recall was initiated because the product failed stability specifications, specifically regarding the preservative benazalkonium chloride. The source text indicates the preservative was out of specification.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest…
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 44,448
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 #: 631639
- Exp 01/2017.
Distribution
Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · preservative failure
See all →- ModerateOculus Innovative Sciences Recalls Atrapro Antipruritic Hydrogel Due to Preservative Failure
FDA (Devices) · 2013-03-06
Similar recalls
- HighFluticasone Propionate Nasal Spray Recalled Due to Defective Container
FDA (Drugs) · 2022-07-06
- HighFluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns
FDA (Drugs) · 2023-06-07
- HighApotex Recalls Fluticasone Propionate Nasal Spray Due to Glass Particles
FDA (Drugs) · 2018-06-13
- HighFluticasone Propionate Nasal Spray Recalled for Potential Bacterial Contamination
FDA (Drugs) · 2024-02-28
- ModerateAzelastine Hydrochloride Nasal Spray Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-06-07
- ModerateAkorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination
FDA (Drugs) · 2020-07-22