Recalls / Class II
Class IID-0508-2020
Product
Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
- Affected lot / code info
- All Lots
Why it was recalled
Lack of Processing Controls
Recalling firm
- Firm
- Integrated Health Concepts Inc. dba Conversio Health
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 720 Aerovista Pl Ste D, N/A, San Luis Obispo, California 93401-8726
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-11-12
- FDA classified
- 2019-11-19
- Posted by FDA
- 2019-11-27
- Terminated
- 2020-05-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0508-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.