The Recall Desk
LowFDA (Drugs)·D-382-2014·Announced 2014-01-01

Teva Recalls Qnasl Nasal Aerosol Due to Potential Clogged Stem Valves

Teva Pharmaceuticals USA is recalling Qnasl Nasal Aerosol units because some may have clogged stem valves, potentially affecting delivery.

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

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray. The recall involves 379,463 inhalers distributed nationwide and in Puerto Rico. The affected lots are 120004, 120095, 120131, 120131 2, 120271, and 120351, with expiration dates ranging from January 2014 to August 2014.

The recall was initiated due to a defective delivery system. There is a potential for some units in these lots to have clogged stem valves, which may prevent the medication from being delivered properly. The FDA has classified this as a Class III recall, indicating that the defect is not likely to cause adverse health consequences.

Consumers with these specific lots of Qnasl should stop using the product and contact their healthcare provider or pharmacist for a replacement or further instructions. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments if necessary.

The recalled product

Product
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
Affected units
379,463

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 (10)

  • Lot #: 120004
  • Exp 01/14
  • 120095
  • 120131
  • 120131 2
  • Exp 03/14
  • 120271
  • Exp 07/14
  • 120351
  • Exp 08/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: