Drug product
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
D-0626-2017
Product summary
- Event
- Event 76839
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 593,088 inhalers
- Official record key
drug-enforcement:D-0626-2017
Official wording
Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Code information: Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification