Why it was recalled
Lack of Processing Controls
Product description
Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide in the U.S.
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-0507-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Integrated Health Concepts Inc. dba Conversio Health
Original FDA data
Every field from FDA enforcement report D-0507-2020, exactly as published.
Show all FDA fields
- City
- San Luis Obispo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84284
- Address
- 720 Aerovista Pl Ste D
- Code information
- All Lots
- Postal code
- 93401-8726
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0507-2020
- Classification
- Class II
- Recalling firm
- Integrated Health Concepts Inc. dba Conversio Health
- Termination date
- May 28, 2020
- Reason for recall
- Lack of Processing Controls
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Nov 12, 2019
- Initial firm notification
- Telephone
- Center classification date
- Nov 19, 2019