Why it was recalled
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Product 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.
Lot numbers, UPCs & expiration codes
Lot # 150328, Exp 10/17
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-1453-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 15, 2016
- FDA report date
- Aug 10, 2016
- Quantity
- 193,320 canisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1453-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74700
- Address
- 425 Privet Rd
- Code information
- Lot # 150328, Exp 10/17
- Postal code
- 19044-1220
- Report date
- Aug 10, 2016
- Product type
- Drugs
- Recall number
- D-1453-2016
- Classification
- Class III
- Recalling firm
- Teva North America
- Product quantity
- 193,320 canisters
- Termination date
- Mar 10, 2017
- Reason for recall
- Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 15, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2016