Agency classClass IIIOur severity:Low FDA (Drugs)·D-0170-2017·Announced 2016-12-14

Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

Teva Pharmaceuticals is recalling Qnasl nasal aerosol canisters because the product failed stability testing for spray content uniformity.

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 as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Teva Pharmaceuticals USA is recalling Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays. The recall involves 201,234 canisters distributed nationwide. The affected lots are 150096 (Exp. 3/2017) and 150327 (Exp. 10/2017), with NDCs 59310-206-06 and 59310-206-08. These are physician samples.

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.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance. The FDA has classified this as a Class III recall, indicating a remote possibility of adverse health consequences.

The recalled product

Product: Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Nasal Aerosol
Hazard: content-uniformity

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 (4)

Lot #: 150096
Exp. 3/2017
Lot #: 150327
Exp. 10/2017

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.

See all 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · content uniformity