Status
Terminated
Drug Enforcement D-1691-2012
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
Classification
Class II
Report Date
October 3, 2012
Termination Date
November 1, 2012
Product Information
- Product description
- 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
- Product quantity
- 18 Inhalers
- Reason for recall
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US: IN & WI
Location & Firm
- Recalling firm
- Dispensing Solutions, Inc
- Address
-
3000 W Warner Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1691-2012
- Event ID
- 63095
- Recall initiation date
- August 28, 2012
- Center classification date
- September 25, 2012
- Code info
- Lot # F23989, F22311
- More code info
- —