Drug 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.
D-1453-2016
Product summary
- Event
- Event 74700
- Status
- Terminated
- Classification
- Class III
- Quantity
- 193,320 canisters
- Official record key
drug-enforcement:D-1453-2016
Official wording
Reason: Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Code information: Lot # 150328, Exp 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification