Drug product
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
D-1666-2012
Product summary
- Event
- Event 62799
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,412,566 inhalers
- Official record key
drug-enforcement:D-1666-2012
Official wording
Reason: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Code information: Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.