Drug product
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
D-0793-2017
Product summary
- Event
- Event 77329
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 562,883
- Official record key
drug-enforcement:D-0793-2017
Official wording
Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate
Code information: Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification