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
FDA recall notice · announced October 3, 2012 · Dispensing Solutions
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
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
Notes
Distribution: US: IN & WI
Lot/code information: Lot # F23989, F22311
Quantity: 18 Inhalers
Status: Terminated
Products in this recall event:
- 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 produc (D-1691-2012)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.