Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure
Teva Pharmaceuticals USA is recalling Qnasl nasal aerosol because stability testing showed the product failed content uniformity specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 documentation or specification issues without reported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays. The recall affects products with Lot numbers 150335 and 150336, which have an expiration date of 4/2017. The product is distributed nationwide.
The recall was initiated because the product was out of specification for spray content uniformity during stability testing. This means the amount of medication in each spray may not be consistent with the required standard.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating the product is unlikely to cause adverse health consequences.
The recalled product
- Product
- Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Nasal Aerosol
- 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 (3)
- Lot #: 150335
- 150336
- Exp. 4/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA 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.
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