Drug product
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland
D-0573-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26895 inhalers
- Official record key
drug-enforcement:D-0573-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: DAF02A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations