Key Takeaway

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 Respirator by Teva North America was recalled on July 15, 2016. The hazard: Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

FDA Drug Class III Terminated

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 Respirator

Recalled: July 15, 2016 ~193,320 canisters units affected D-1453-2016

Description

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; NDC 59310-206-08.

Hazard / Reason

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 Respirator

Drugs

Company Information

Teva North America

Horsham, PA, United States

View all 12 recalls by Teva North America →

Distribution

Nationwide

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Frequently Asked Questions

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