Drug product
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
D-1691-2012
Product summary
- Event
- Event 63095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 Inhalers
- Official record key
drug-enforcement:D-1691-2012
Official wording
Reason: Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Code information: Lot # F23989, F22311
Distribution pattern: US: IN & WI
Derived failure modes
-
Labeling or packaging
Label Mix up