Why it was recalled
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-382-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 4, 2013
- FDA report date
- Jan 1, 2014
- Quantity
- 379,463 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-382-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67010
- Address
- 425 Privet Rd
- Code information
- Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
- Postal code
- 19044-1220
- Report date
- Jan 1, 2014
- Product type
- Drugs
- Recall number
- D-382-2014
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 379,463 inhalers
- Termination date
- Aug 27, 2014
- Reason for recall
- Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2013