Teva Recalls Children's Qnasl Nasal Aerosol for Content Uniformity Failure
Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva North America is voluntarily recalling 193,320 canisters of Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol. The product is a prescription-only nasal spray manufactured for Teva Respiratory, LLC, and distributed nationwide. The specific lot affected is # 150328, with an expiration date of 10/17.
The recall was initiated because the product failed content uniformity specifications, specifically resulting in an out-of-specification test result for spray content uniformity. This means the amount of medication in each spray may not be consistent with the required standards.
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324;
- Manufacturer
- Teva North America
- Category
- Drug — Nasal Aerosol
- Hazard
- Affected units
- 193,320
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 # 150328
- Exp 10/17
Distribution
Distributed nationwide across the United States.
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