FDA Drug Recalls

Recalls / Class II

Class IID-0512-2020

Product

Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, 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-0512-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.