Recalls / Class III
Class IIID-0170-2017
Product
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).
- Affected lot / code info
- Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017
Why it was recalled
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 201, 234 Canisters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-01
- FDA classified
- 2016-12-08
- Posted by FDA
- 2016-12-14
- Terminated
- 2018-02-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0170-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.