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.
What this means for you
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
- stability-unverified
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.
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