Why it was recalled
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Product description
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).
Lot numbers, UPCs & expiration codes
Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017
Where it was sold
Nationwide
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-0170-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 1, 2016
- FDA report date
- Dec 14, 2016
- Quantity
- 201, 234 Canisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0170-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 75565
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017
- Postal code
- 19454-1505
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0170-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 201, 234 Canisters
- Termination date
- Feb 6, 2018
- Reason for recall
- Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 1, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2016