Drug product
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
D-0171-2017
Product summary
- Event
- Event 75565
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0171-2017
Official wording
Reason: Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Code information: Lot #: 150335, 150336, Exp. 4/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification