D-1691-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2012
- Initiation Date
- August 28, 2012
- Termination Date
- November 1, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 Inhalers
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
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
Distribution Pattern
US: IN & WI
Code Information
Lot # F23989, F22311