Why it was recalled
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
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
Lot numbers, UPCs & expiration codes
Lot # F23989, F22311
Where it was sold
US: IN & WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1691-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 18 Inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dispensing Solutions, Inc
Original FDA data
Every field from FDA enforcement report D-1691-2012, exactly as published.
Show all FDA fields
- City
- Santa Ana
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63095
- Address
- 3000 W Warner Ave
- Code information
- Lot # F23989, F22311
- Postal code
- 92704-5311
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1691-2012
- Classification
- Class II
- Recalling firm
- Dispensing Solutions, Inc
- Product quantity
- 18 Inhalers
- Termination date
- Nov 1, 2012
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US: IN & WI
- Recall initiation date
- Aug 28, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2012