Recalls / Class III
Class IIID-1453-2016
Product
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.
- Affected lot / code info
- Lot # 150328, Exp 10/17
Why it was recalled
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 193,320 canisters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-15
- FDA classified
- 2016-08-02
- Posted by FDA
- 2016-08-10
- Terminated
- 2017-03-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1453-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.