Drug 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).
D-0170-2017
Product summary
- Event
- Event 75565
- Status
- Terminated
- Classification
- Class III
- Quantity
- 201, 234 Canisters
- Official record key
drug-enforcement:D-0170-2017
Official wording
Reason: Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Code information: Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification