Roxane Recalls Azelastine Nasal Spray Due to Defective Delivery System
Roxane Laboratories is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Spray because the delivery system failed droplet size testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor defects or documentation issues.
Plain-English summary
Roxane Laboratories, Inc. is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles. The product is distributed by West-Ward Pharmaceuticals Corp. and is available by prescription only. The affected product is identified by Lot # 659365A with an expiration date of 3/31/2018.
The recall was initiated due to a defective delivery system. Specifically, the product failed to meet specifications for droplet size distribution at the d90 measurement testing during the 6-month time point. This defect may affect the performance of the nasal spray.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
- Manufacturer
- Roxane Laboratories, Inc.
- Category
- Drug — Nasal Spray
- Affected units
- 74,108
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 # 659365A
- Exp 3/31/2018
Distribution
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